[c09aa8]: / clusters / clustall9k / 159.txt

Download this file

284 lines (283 with data), 40.4 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
No prior radiation therapy to the head and neck; prior radiation therapy to body sites other than the head and neck are permitted provided that the treating radiation oncologist determines that there is no overlap between the head and neck radiation plan and the prior radiation fields
Participants who have had prior radiation therapy to the head and neck
No active malignancy; participants that received curative treatment for a prior cancer are eligible provided there is no prior head and neck radiation and no prior chemotherapy or anti-EGF or anti-HER2 therapy as above
Patients with prior radiation to the head and neck
Prior history of radiation therapy to the head and neck
Prior history of head and neck cancer
Must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region
Prior radiation to the head and neck
Prior radiation to the head and neck region
COHORT I: History of radiation to the head and neck area (defined as above the clavicles) greater than 6 months previous
Prior treatment for head and neck cancer
Prior head and neck radiation
Previous radical radiation therapy to the head and neck, excluding superficial radiation therapy to cutaneous SCC or basal cell carcinoma, which is not within or overlapping the tumour bed
Prior head and neck radiation, chemotherapy, or immunotherapy
Prior radiation therapy to the chest, neck or axilla
Prior radiation therapy to head and neck region that would overlap with intended radiation treatment for nasopharyngeal carcinoma
Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
Prior therapy for head and neck cancer is allowed, and the number of treatments is not limited; however, any systemic therapy should have been completed at least 30 days prior to study enrollment; any radiation to the head and neck should have been completed at least 30 days prior to study enrollment; palliative radiation outside of the\r\nhead and neck does not require a washout
Prior radiation therapy to the head and neck region.
No previous radiation or chemotherapy for a head and neck cancer
Patients may have a history of prior head and neck malignancy, but must be able to tolerate full dose radiation and chemotherapy for the current head and neck cancer, as determined by the treating oncologist
No prior chemotherapy for the current locally advanced SCCHN is allowed; prior radiation or chemotherapy for a previous head and neck cancer is allowed provided full dose cisplatin and radiation can be delivered to the patient in this clinical trial and provided the patient is in remission from the prior head and neck cancer, and can undergo full dose radiation and chemotherapy for the current primary head and neck cancer
Patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap
Prior head and neck radiation or prior chemotherapy for head and neck squamous cell carcinoma (HNSCC)
No prior systemic (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer\r\n* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed\r\n* Patients must be untreated with radiation above the clavicles
Prior treatment with radiation to the head and neck
Radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
Having received radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
Determined by the treating physician to be a candidate for organ preserving, concurrent standard chemotherapy and radiation therapy to the head and neck with definitive intent
Prior radiation therapy to the head and neck
Prior radiation therapy to the head and neck
Radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
Prior head and neck radiation or prior chemotherapy
Patients with prior radiation to the head and neck
Prior radiation to the head and neck
Prior radiation therapy to the head and neck
Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap.
No prior systemic chemotherapy, systemic biologic/molecular targeted therapy or radiation treatment for head and neck cancer
History of radiation to the head and neck (above the clavicles)
Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
Previous head and neck radiation therapy
No prior systemic (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer\r\n* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed\r\n* Patients must be untreated with radiation above the clavicles
Prior history of radiation to the head and neck region
Patients receiving any prior radiation therapy to the head or neck
Prior head and neck radiation or chemotherapy
Patients with head and neck cancer recurrence requiring surgery with no history of prior chemotherapy or radiation therapy are considered eligible
Patients must not have had any prior chemotherapy or radiation therapy for head and neck cancer treatment
Prior head and neck radiation or chemotherapy
Unilateral neck radiation
A history of prior radiation to the head and neck (>= 40 Gy, in 2 Gy/fraction equivalent)
Any prior head or neck irradiation
Prior radiation therapy to the head and neck region
Any prior known radiation therapy in head and neck area
Prior radiation to the head or neck with overlapping radiation fields
No previous radiation or chemotherapy for a head and neck cancer
No prior chemotherapy for the current locally advanced squamous cell carcinoma of the head and neck (SCCHN); prior radiation or chemotherapy for a previous head and neck cancer is allowed provided full dose radiation can be delivered to the current treatment and provided the patient remains in remission for greater than 3 years from prior diagnosis
Patients may have a history of prior malignancy, but must be able to tolerate full dose radiation and chemotherapy for the current head and neck cancer, as determined by the treating oncologist
Previous head and neck radiation therapy involving the glottic larynx
Prior therapy to the head and neck, with the intent to treat, the current diagnosis of head & neck cancer
Subjects with prior head and neck radiation therapy
Patients who had prior head and neck radiation therapy
Previous irradiation for head and neck tumor; concurrent chemotherapy other than the treatment per protocol; previous chemotherapy =< 3 months from start of radiation therapy (RT)
Prior radiation to the head and neck
Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
Patients with prior primary treatment for head and neck cancer (e.g. chemoradiation or radiation alone).
Prior radiation to the head and neck.
No prior radiation therapy to the chest, neck or axilla
Received previous radiation treatment for head and neck cancer
Patient is initiating radiation therapy (XRT) for head and neck cancer (HNC)
Patient has no history of prior neck surgery or external radiation to neck for malignant conditions
Patients with head and neck cancer who plan to undergo radiation therapy to the head and neck region
Patients with prior radiation therapy to the head and neck region or prior chemotherapy for head and neck cancer (induction chemotherapy not excluded)
Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy
Patients actively receiving radiation to the head, neck, or gastrointestinal tract
Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer
Subjects with a diagnosis of head and neck cancer biopsy proven, and who are candidates for radiation therapy
Prior head and neck radiation treatment
Prior history of radiation therapy to the head and neck
Prior history of head and neck cancer
Prior head and neck radiation treatment
Has had prior radiation to the head and neck
Patients who are scheduled to undergo radiation or chemoradiation treatment for head/neck cancer
Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only)
Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
Previous or concurrent radiation treatment to the head and neck region
Prior head and neck RT
Prior radiation to the head and neck
Patients with previous head and neck (H&N) radiation
History of xerostomia, Sjogren’s disease or other illness known to affect salivation prior to head/neck radiation
Subject has received prior radiation to the head and neck region (+/- chemotherapy).
No prior radiation therapy to the head and neck area, and no chemotherapy within the last year except for induction chemotherapy delivered (or to be delivered) prior to the current course of radiation therapy
Within two weeks of starting or one week from having started, radiation therapy +/- chemotherapy for head and neck cancer
History of prior surgery or radiation to the head, neck, upper limb, or trunk
Any prior radiotherapy to the head and neck region
Patient must not have a history of radiation to the neck
Patients with history of prior radiation therapy or radioactive iodine to the head and neck
Diagnosed Head and Neck Cancer patients with planned Radiation therapy
Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors
Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI.
Patients must have an immune checkpoint resistant malignancy (for example, RCC, head and neck carcinoma or MSI high cancers which have approved settings for anti-PD1 treatment), confirmed histologically or cytologically.
COHORT I: Pathologically proven recurrent disease or a second primary (squamous cell carcinoma of the head and neck, nasopharyngeal cancer, or salivary gland cancer) within the head and neck region, deemed to be unresectable or resected with gross residual disease remaining or microscopically positive margins defined as closer than 5mm (determined by either operative/pathology report or postsurgical imaging)
COHORT II: Pathologically proven solid tumor in the head and neck that are amenable to palliative treatment
In the opinion of the local PI: Head and neck cancer patients with airway tumor recurrence that may compromise breathing or swallowing if inflammation or edema is transiently aggravated by Hiltonol injection. Head and neck cancer patients with tumor invading major blood vessels for whom there may be a risk of blockage or bleeding if inflammation or edema is transiently increased by Hiltonol injections.
Tumour located above the clavicle and below the jaw or occiput (neck primary) or above the jaw/occiput (head primary)
Prior chemo therapy or radiosensitizer for head and neck cancer
Patients must be evaluated by a head and neck surgeon and be deemed surgically resectable at baseline
A previous diagnosis of histologically defined head and neck cancer.
The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
Facial or head and neck dermal metastasis.
No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
Surgical resection of head and neck must be planned, either as primary treatment or salvage; patients must undergo research biopsy prior to receiving drug
Malignancies resulting in cutaneous metastasis originating from: breast, lung, head and neck, pancreatic, urinary bladder, prostate, testicular, ovarian, uterine, cervical, gastric, adrenal, thyroid, parathyroid cancers, or other solid tumors which previously responded to taxane treatment;
Patients with distant metastatic disease (M1c) from the current head and neck cancer including brain metastasis
Examination by an ear/nose/throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to enrollment.
History of any other cancer other than head and neck cancer (HNC) (except carcinoma in situ of the cervix) within the last 5 years.
Subjects must have histologically or cytologically confirmed recurrent head and neck cancer
Patients must have pretreatment neck and chest imaging
Pathologically proven recurrent or second-primary head-and-neck cancer receiving prior radiotherapy with or without chemotherapy
ARM B COHORT 2: Patients with head and neck cancer must not have radiologic evidence of major arterial involvement
Subjects with a diagnosis of recurrent head and neck cancer
Neck adenopathy that involves the overlying skin
Initial surgical treatment including tonsillectomy or neck dissection, but excluding diagnostic biopsy of the primary site or nodal sampling of neck disease
Presence of N0 or N1 disease in neck dissection
Patients with stage III/IV per tumor/nodes/metastasis (TNM) guidelines for head and neck sites (American Joint Committee on Cancer [AJCC] 7th Edition), locally advanced, biopsy proven squamous cell cancer of the head and neck that undergo chemoradiation as their primary treatment with curative intent; patients with oropharynx (human papillomavirus [HPV] positive and HPV negative), hypopharynx, larynx primaries, nasopharynx as well as those with documented squamous cell cancer (SCC) of the cervical lymph nodes, with unknown primaries, are eligible
Patients who have received prior radiation to the head and neck or adjacent anatomical site (e.g., upper lobe lung, brain)
Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
Primaries on the torso, upper and lower extremities and head and neck region
Previous irradiation for head and neck tumor, skull base, or brain tumors
Previous head and neck surgery that would preclude transoral/robotic procedures; this is at the investigator’s discretion; this is not an exclusion criterion for the non-surgical arm
Head and neck oropharyngeal, hypopharyngeal, or oral cavity lesions requiring surgical resection, biopsy, or invasive treatment
Carotid artery involvement by tumor had a neck dissection on that side
Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.
All HNSCC lesions should be in the head and neck region and suitable for intra-tumoral injection
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b cancer:\r\n* Involvement of pterygopalatine fossa, maxillary sinus, or facial skin\r\n* Gross extension of tumor to the skull base\r\n* Pterygoid plate erosion\r\n* Sphenoid bone or foramen ovale involvement\r\n* Direct extension to involve prevertebral fascia\r\n* Extension to superior nasopharynx or Eustachian tube\r\n* Direct extension into the neck with involvement of the deep neck musculature (neck node fixation)\r\n* Suspected invasion (encasement) of the common or internal carotid arteries; encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery 270 degrees or greater\r\n* Direct extension of neck disease to involve the external skin\r\n* Direct extension to mediastinal structures\r\n* Regional metastases to the supraclavicular neck (low level VB and IVB)
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Tumor involvement of the following sites or any of these signs or symptoms likely to be associated with T4b cancer:\r\n* Involvement of pterygopalatine fossa, maxillary sinus\r\n* Gross extension of tumor to the skull base\r\n* Pterygoid plate erosion\r\n* Sphenoid bone or foramen ovale involvement\r\n* Direct extension to involve prevertebral fascia\r\n* Extension to superior nasopharynx or Eustachian tube\r\n* Direct extension into the neck with involvement of the deep neck musculature (neck node fixation)\r\n* Suspected invasion (encasement) of the common or internal carotid arteries; encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery 270 degrees or greater\r\n* Direct extension of neck disease to involve the external skin\r\n* Direct extension to mediastinal structures\r\n* Regional metastases to the supraclavicular neck (low level VB and IVB)
Examination by Radiation Oncologist, Medical Oncologist, and Ear, Nose, Throat (ENT) or Head & Neck Surgeon within 28 days prior to registration
Patients with oral cavity cancer are excluded from participation if resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist.
Patients must have stage III-IVB head and neck squamous cell carcinoma (HNSCC) (American Joint Committee on Cancer [AJCC] seventh [7th] edition) based on the following minimum diagnostic workup within 60 days prior to step 1 registration: \r\n* General history and physical examination by a radiation oncologist, medical oncologist, and/or ear, nose and throat (ENT) or head & neck surgeon\r\n* For larynx, hypopharynx, and base of tongue primaries, a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is required, unless the patient cannot tolerate or refuses\r\n* Imaging of the head and neck with a neck CT or magnetic resonance imaging (MRI) (with contrast, unless contraindicated) or PET/CT (with contrast, unless contraindicated)\r\n* Chest imaging: chest CT with and without contrast (unless contraindicated) or PET/CT
Patients with metastatic disease beyond the neck and supraclavicular region will be excluded
Prior chemotherapy or radiotherapy for the diagnosis of GBM or for cancers of the head and neck
Any head and neck subsite other than oropharynx (including unknown primary site)
Prior head and neck malignancy or history of other prior non-head and neck malignancy (excluding skin cancer and early stage treated prostate cancer) within the past 3 years
Patients with concurrent primary head and neck tumors that will be resected as part of treatment plan are considered eligible
Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer)
Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, or recurrent neck metastases with unknown primary; exception from pathology confirmation of tumor recurrence is accepted for patients who originally had pathologically confirmed SCC of the Head and Neck, the new tumor is located in the head and neck area and it is clinically considered as a recurrence of the original tumor, and a tumor biopsy is technically difficult and would expose the patient to unjustified risk; the treating physicians should agree and document the clinical definition of tumor recurrence and should document the increased risk for biopsy
Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
Examination by an ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to entering the study.
Patients with initial surgical treatment, radical or modified neck dissection.
direct extension into the neck with involvement of the deep neck musculature (neck node fixation);
direct extension of neck disease to involve the external skin;
Urethral stricture/bladder neck contracture
Must have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole).
Patients must have histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B (larynx, oral cavity, oropharynx and hypopharynx or unknown primary isolated to the head and neck region) and select stage II tumors of the base of the tongue (BOT) (size more than 3 cm), who are appropriate for potentially curative therapy with chemoradiotherapy or surgical resection, as determined by the multidisciplinary head and neck cancer clinical care and research team
Prior chemotherapy for the current SCCHN will not be allowed; patients with second primary cancers of the head and neck who remain in remission for 3 years from the prior diagnosis are eligible for this study, provided they may receive full dose radiation to the current SCCHN cancer
Patients may have received induction therapy prior to definitive therapy for the current head and neck cancer
Patient with newly diagnosed or recurrent, histologic diagnosis of lung cancer or head & neck cancer (categories: oral cavity, pharynx and larynx only)
Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s)
Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied
Reirradiation targets located within the head, neck, or brain are excluded from this study
Any N stage but resectable; lymph nodes in both sides of the neck are at risk of metastatic disease, according to clinical judgment, and require irradiation; pre-treatment surgery in the neck in the forms of incisional/excisional biopsy or a multilevel neck dissection is allowed only if there is gross tumor left at the primary site
Patients with prior history of head and neck radiotherapy (> 40 Gy) with significant areas of anticipated overlap
confirmed SCC of the head and neck, lung, or esophagus
Histologic or cytologic confirmation of head and neck malignancy without clinical or radiographic evidence of metastatic disease
Subjects with a diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at Thomas Jefferson University Hospital (TJUH) are eligible to participate
Participants with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria
Diagnosis of any of the following cancers: stage 1-4b (includes 4a) oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b (includes 4a) laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; any thyroid cancer that will be addressed with treatment to the bilateral necks; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs)
Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
Patients undergoing free flaps for reconstruction of head and neck surgical defects at University of California (UC) Davis Medical Center (UCDMC), including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
Patients must be diagnosed with cancer of the head and neck and must be surgical candidates
History of head injury
Completed treatment for a head or neck cancer at this institution within 4 months of consent OR will complete treatment for a head and neck cancer at this institution within 3 weeks of consent
Patients receiving brain RT for intracranial disease (including recurrent head and neck tumors with base of skull or intracranial extension) or for prophylactic cranial irradiation, over 2-6 weeks period of time
Patient requires a neck brace for medical reasons
Full range of motion in the neck
Limited neck movement
Histologically proven cancer of the head and neck cancer
Cervical or head/neck cancer diagnosis in the past 5 years
Patients with a definitive, curative treatment plan consisting of chemoradiation for head & neck cancer\r\n* Surgery, if required, must be limited to: diagnostic biopsy
Patients who are eligible for chemoradiation therapy of the head and neck
Have a clinical stage II-IV head and neck carcinoma
Diagnosed with head and neck cancer, which will be primarily nasopharyngeal, and scheduled to undergo intensity-modulated radiation therapy (IMRT) or proton with or without concurrent chemotherapy at MD Anderson or Fudan University
Previous receipt of head and neck irradiation
Patients with head and neck cancer who are undergoing either flap or nonflap surgery (limited to parotidectomy, hard palate maxillectomy and glossectomy, mandibulectomy, and any procedure with neck dissection) at MD Anderson Cancer Center
> 3 months post-treatment of head and neck cancer (HNC)
Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo intensity modulated radiation therapy (IMRT) with or without concurrent chemotherapy at M. D. Anderson
Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap
Personal history of lung cancer or head and neck cancer
Patients must be receiving cisplatin therapy for a non-head and neck malignancy in total doses >= 100 mg/m^2
Patients must be scheduled to receive RT or CRT as definitive treatment or adjuvant RT or CRT treatment post-surgery per surgeon or Head and Neck Cancer (HNC) Tumor Board decision
Urethral stricture/bladder neck contracture
Must have a diagnosis of head/neck cancer
Must have anatomically intact parotid glands and at least one submandibular gland; a focused (head/neck) history and exam conducted by a physician or dentist within the past year is required
Personal history of lung cancer or head and neck cancer
Subjects with head and neck cancer involving the oropharynx or oral cavity, who are expected to undergo high dose radiation therapy (i.e., ? 60 Gy) that typically results in oral mucositis, with or without concurrent chemotherapy or biologic targeted therapy.
diagnosis of head and neck cancer
Evidence of current disease with lung cancer or head and neck cancer
Patients may have a prior history of lung cancer or head and neck cancer treated with curative intent, provided that there has been no evidence of disease (NED) for > 1 year; the qualifying autofluorescence (AF) bronchoscopy must be negative for malignancy
Diagnosed with melanoma or lymphoma cancer of the head and neck
Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region
Confirmed or suspected head and neck tumor (benign or malignant)
Adult patients seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract (UADT)
Adult subjects with brain, head and neck, and skull base tumors receiving external beam proton radiotherapy on gantry at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (MGH)
Patients with histologically proven diagnosis of head and neck cancer or patients with tumors strongly suspicious for head and neck cancer due to clinical features or FNA (fine needle aspiration) cytology assessment
Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection, including a (modified) neck dissection
Participant with unilateral or bilateral neck dissection planned for care; an N0 neck must be planned to be dissected for the patient to be eligible; the N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned
Participant in whom it may be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis (see definition above);\r\n* These will include: 1) oral cavity cancer; 2) oropharynx cancer, including base of tongue and tonsil cancers; 3) larynx cancer; or 4) supraglottic cancer
Patient with tumors in the head and neck that are not SCC
Patients with head and neck cancer who are scheduled for node dissection surgeries at New York University (NYU) Langone Medical Center or Bellevue hospital, or for a PET/CT at the Cancer Center (160 E 34th St) for treatment planning are eligible
Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection; patients with recurrent disease or a new primary will be allowed
Patients must have had pathologic lymph nodes in the neck, axillary or inguinal area (do not need to be biopsy proven) from either leukemias, lymphomas; head and neck cancers (e.g. tonsillar, nasopharynx, tongue carcinoma), breast cancer or melanoma; or thyroid cancer for thyroid ablation therapy; any other more infrequent cancer with nodal metastasis in the neck, axilla, and inguinal regions is eligible as well as the primary goal is to image pathological (i.e. hypermetabolic) lymph nodes
Patients with indications for initial total thyroidectomy (TT) including preexisting hypothyroidism or history of head and neck radiation when < 18 years old will be excluded.
Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck,\r\nrenal, breast, lung, ovary, liver)
Patients with a diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at Thomas Jefferson University Hospital (TJUH) are eligible to participate
Patients with neck dissection connected to upper aerodigestive tract
Pre-intervention: 200 patient records between January 1, 2016 and December 31, 2016 are subject to review; the first 50 records with a diagnoses of each cancer type: head and neck, lung, prostate, or breast will be utilized for the review
Post-intervention: 200 patient records receiving care beginning six months post training are subject to review; the first 50 records with a diagnoses of head and neck, lung, prostate, or breast will be utilized
Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3)
Planned RT to the head/neck
Patients must have histologically confirmed head-and-neck, lung, or prostate tumors
Subjects have head and neck cancer as defined in history and physical
History of prior surgery on the oropharynx, neck, esophagus, or stomach
History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
Edema or lymphedema in the lower limbs > grade 2
A diagnosis of head and neck lymphedema.
Completion of phase 1 lymphedema care in the past 8 weeks;
Inclusion Criteria:\n\n 1. Has a diagnosis of secondary leg lymphedema, based on a positive lymphoscintigraphy\n (LSG) study of the affected leg OR has a diagnosis of primary lymphedema not of\n congenital onset affecting one or both lower limbs, based on positive LSG.\n\n 2. Swelling of at least 1 leg not completely reversed by leg elevation or compression.\n\n 3. Stage II or greater lymphedema, based on the International Society of Lymphology (ISL)\n staging system.\n\n 4. Completion of a full course of complete decongestive therapy (CDT).\n\n 5. Stable limb volume (within 10% during screening for worse/affected leg) .\n\n 6. If patient has had a lymphatic vascularization procedure (lymphovenous bypass or lymph\n node transfer) or liposuction for lymphedema in the affected limb, then procedure must\n have been performed at least 1 year (12 months) prior to Screening AND affected limb\n must be clinically stable over the 3 months prior to Screening AND significant\n residual disease must be present.\n\n 7. Ambulatory status (use of a walking aid is permitted).\n\n 8. Agree to use a medically acceptable method of contraception, if the possibility of\n conception exists.\n\n Exclusion Criteria:\n\n Exclusions Based on Lymphedema:\n\n 1. A diagnosis of primary lymphedema with congenital onset. Primary lymphedema is defined\n as lymphedema with onset prior to or without an inciting event (e.g, surgery, trauma,\n radiation)\n\n 2. Occurrence of significant lymphedema of another body part that is not the lower limb\n (e.g, upper extremity, trunk, head and neck, genitalia).\n\n 3. Lymphedema involving all four limbs\n\n 4. Recent initiation of, or intention to initiate CDT or maintenance physiotherapy for\n lymphedema.\n\n Exclusions Based on Other Medical Conditions\n\n 5. Deep venous thrombosis in either lower limb or systemic anticoagulation within 6\n months\n\n 6. Other medical condition that could lead to acute or chronic leg edema.\n\n 7. Other medical condition that could result in symptoms overlapping those of lymphedema\n in the affected leg.\n\n 8. History of clotting disorder (hypercoagulable state).\n\n 9. Chronic (persistent) infection in either lower limb.\n\n 10. Cellulitis or other infection in either lower limb or use of antibiotics for\n cellulitis within 3 months prior to screening.\n\n 11. Other unstable or severe medical condition requiring active management and/or likely\n to decompensate/require active management within the next year\n\n 12. Current evidence of malignancy.\n\n 13. History of malignancy within the previous 3 years, except for nonmelanoma skin cancer\n or cervical carcinoma in situ treated with curative intent.\n\n 14. Currently receiving chemotherapy or radiation therapy.\n\n 15. Life expectancy < 2 years for any reason.\n\n 16. Pregnancy or nursing.\n\n 17. Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening.\n\n Exclusions Based on Concurrent Medication Use\n\n 18. Regular concurrent use or regular use within 6 months before screening of another\n leukotriene pathway inhibitor.\n\n 19. Concurrent antibiotic use.\n\n 20. Concurrent use of any agent active on the sphingosine-1-phosphate (S1P) pathway.\n\n 21. Concurrent use of unapproved (including herbal) treatments for lymphedema.\n\n Exclusions Based on Laboratory Values\n\n 22. Significant or chronic renal insufficiency or requires dialytic support.\n\n 23. Hepatic dysfunction.\n\n 24. Absolute neutrophil count <1500 mm3 at screening.\n\n 25. Hemoglobin concentration <9 g/dL at screening.
Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
Unstable lymphedema (i.e. worsening symptoms/measurements in the past 3 months)
Stage III lymphedema
Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment
Have arm lymphedema on one side only
Lymphedema Group: Lymphedema, symptomatic of stage II or III based upon screening responses; or lymphedema index (L-Dex) reading of >= 7 at initial visit
Lymphedema Group: > 3 months (mths) post-breast cancer treatment
Lymphedema Group: No active cancer
Lymphedema Group: Has compression sleeve
Lymphedema Group: Willing to do guided and home yoga practice
Lymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
Lymphedema Group: Medical clearance
Lymphedema Group: Reliable transportation to the study site
No Lymphedema Group: No known lymphedema or intermittent swelling, not symptomatic of stage II or III lymphedema (L-Dex >= 7)
No Lymphedema Group: > 3 mths post- breast cancer treatment
No Lymphedema Group: No active cancer
No Lymphedema Group: Willing to do guided and home yoga practice
No Lymphedema Group: Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire
No Lymphedema Group: Medical clearance
No Lymphedema Group: Reliable transportation to the study site
Current lymphedema treatment
No more than 6 weeks after completion of initial lymphedema therapy for head and neck lymphedema
Stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
Presence of other extremity lymphedema (primary or secondary)
No active lymphedema
Unmanaged lymphedema
Patients may or may not have a history of lymphedema or have been treated for lymphedema
Patients who have lymphedema due to cancer recurrence
Lymphedema of the upper extremities, as detected on history and physical
Previous diagnosis of lymphedema
Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted)
Prior diagnosis of lymphedema
Unilateral upper limb secondary lymphedema
Intermediate phase lymphedema; defined clinically as significant persistent pitting edema on physical exam
Patient undergoing concomitant treatment for upper extremity lymphedema, or who have received treatment within the last 14 days
Patients on diuretics solely for treatment of lymphedema are excluded
Patient with primary lymphedema; if edema can be explained by systemic or congenital illnesses, that patient will not be eligible for this study
Patients with malignant lymphedema
Grade III lymphedema or lymphedema considered severe by the treating clinician
Knowledgeable in either HNC or lymphedema management or informatics
LYMPHEDEMA THERAPISTS:
Certified lymphedema therapists
Knowledgeable in head and neck lymphedema management
Completion of lymphedema therapy for lymphedema of the head and neck
Able to complete the onsite training and home self-care activities for lymphedema management
Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years; this timeframe allows ample time for any surgically related non-lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study
Bilateral lymphedema
Previous acupuncture treatment for lymphedema
History of primary (congenital) lymphedema
Grade III lymphedema or lymphedema considered severe by the treating clinician
Previous treatment for lymphedema of either arm.
HEALTHY VOLUNTEER: Lymphedema or chronic edema
History of primary lymphedema
Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)