[c09aa8]: / clusters / clustall9k / 492.txt

Download this file

276 lines (275 with data), 26.4 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
Clinical nodal staging of N2 or N3 disease
Pathologic nodal staging of N2b, N2c, or N3 disease
Patients must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:\r\n* Prior chemotherapy for breast cancer\r\n* > 25 cm of breast separation (the largest distance on an axial slice of the planning computed tomography [CT] simulation scan between the entry and exit points of the radiation beam on the body)\r\n* Non-Caucasian race\r\n* Requiring regional nodal irradiation without evidence of N3 disease
Nodal disease as detected by clinical exam or CT
Pathologically confirmed squamous cell carcinoma of the oral cavity; clinical stage >= T2 (primary tumor greater than 2 cm in size) and/or evidence of regional nodal involvement by clinical exam or imaging
Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned
Boosts to the chest wall after mastectomy; nodal boosts are allowed
Nodal recurrences can be treated on this protocol but prior curative surgery for lung cancer must have been at least 6 months prior to the nodal recurrence
Diagnosis of selected stage III or IVa/b head and neck squamous cell carcinoma (HNSCC); all patients must have T2-T4 primary tumors (patients with T1 tumors will be excluded); although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible
ARM 2 - A: Diagnosis of selected stage III or IVa/b HNSCC; all patients must have T2-T4 primary tumors (patients with T1 tumors will be excluded); although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible
Patient with clinically positive nodal disease
Patients with pathologically proven nodal disease
No evidence of in-transit, nodal or distant metastases as determined by clinical examination, CT or MRI
Symptomatic nodal disease (i.e., scrotal, penile, or leg edema)
Tumor > 2.0 cm, nodal involvement, or metastatic involvement
No clinical or pathologic evidence of nodal involvement
Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
Patients who are to undergo definitive chemoradiation must have clinically or radiographically evident measurable disease at the primary site and/or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted.
Clinical evidence of progression of disease > 20% in the breast or new evidence of nodal metastases
Treatment plan that includes regional nodal irradiation
N3 nodal disease
Invasion or ulceration of inguinal nodal disease into the overlying skin
Prior radiation therapy to the same regional nodal basin
Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease
Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis, or at the time of clinically detected nodal and/or in-transit recurrence and may belong to any of the following groups:\r\n* Primary melanoma with clinically apparent (overt) regional lymph node metastases\r\n* Clinically detected recurrence of melanoma at the proximal regional lymph node(s) basin\r\n* Clinically detected primary melanoma involving multiple regional nodal groups\r\n* Clinically detected single site of nodal metastatic melanoma arising from an unknown primary\r\n* Patients with intransit or satellite metastases with or without lymph node involvement are allowed if they are considered potentially surgically resectable at baseline\r\n** NOTE: a patient should be determined to be potentially surgically resectable at baseline to be eligible for this neoadjuvant study
Evidence of nodal involvement identified in the operating room (OR)
Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease (Turnstile I)
No gross vascular invasion or regional nodal or distant metastases
The presence of cervical conglomerate nodal mass or extracapsular spread (ECS) on imaging
Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease (Turnstile I)
Patients must have histologically confirmed (by routine hematoxylin [H] & eosin [E] staining) adenocarcinoma of the breast with confirmed nodal metastasis; patients must have an axillary nodal evaluation by fine-needle aspiration (FNA), sentinel node biopsy (SNB) or nodal dissection; patients with triple negative breast cancer are eligible as long as they are node negative; patients with squamous, or metaplastic carcinomas or sarcomas of the breast are NOT eligible
Patient must have > 1.0 cm residual in-breast cancer and/or clinically positive residual nodal disease
Treatment plan that includes regional nodal irradiation
Patients whose only nodal disease is cystic and not PET-avid
Patients must have measurable disease as per appropriate guidelines:\r\n* Solid tumors: by RECIST v1.1\r\n* Lymphoma: patient has at least one measurable nodal lesion (>= 2 cm) according to Lugano classification; if the patient has no measurable nodal lesions >= 2 cm in the long axis at screening, then the patient must have at least one measurable extra-nodal lesion
Patient has known nodal or distant metastatic disease; patients with nodal or metastatic disease require systemic chemotherapy; furthermore, they should be excluded from this clinical trial because of their poor overall prognosis
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations; tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site; limited neck dissections retrieving =< 4 nodes are permitted and considered as non-therapeutic nodal excisions
Pathologic assessment of the mediastinum to document involved nodal stations
Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis
Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site; nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin and eosin (H & E) stained slides
Patients with multiple regional nodal basin involvement are eligible; gross or microscopic extracapsular nodal extension is permitted
Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.
at least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion ? 5 mm in longest diameter
Histologic diagnosis of melanoma with metastatic disease to a visceral organ (lung, liver, brain, adrenal, nodal station outside the regional lymph drainage of the primary, vertebral bodies)
Evidence of positive nodal disease (stage N1)
Extrahepatic metastases including nodal disease
Patients with metastatic disease involving viscera or bones are ineligible; patients with extensive nodal involvement alone classified as stage IV disease, are eligible
Patient's disease must show extracapsular spread (ECS) in their nodal metastasis
Measurable nodal disease by computed tomography
Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal and/or in-transit metastasis, or at the time of clinically detected nodal and/or in-transit recurrence; patients must undergo biopsy (punch) or open biopsy (if done as part of a clinically indicated baseline diagnostic procedure) within 14 days of entry into the study; lymphadenectomy/definitive surgery will be performed after at least 2 and generally not longer than 4 weeks of induction HDI-ipilimumab therapy; additional delays for definitive lymphadenectomy/surgery are allowed if clinically indicated while awaiting the resolution of potential adverse events from HDI-ipilimumab therapy
Untreated N3 mediastinal nodal disease
Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
Patients with nodal involvement are eligible
Stage 1-3 tumors > 1 cm in maximal diameter, any nodal status, multifocal or multi-centric disease is permitted, no evidence of distant metastases
Subjects with negative nodal status (N0)
Patients with nodal disease are eligible
Known N2 nodal disease or distant metastatic disease
Previously treated, histologically confirmed cluster of differentiation (CD)20+ B cell lymphoma; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra nodal biopsies; fine needle aspirates are not acceptable
Patient has at least one measurable nodal lesion (?2 cm) according to Cheson criteria (Cheson 2007). In case where the patient has no measurable nodal lesions ? 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion.
Presence of active nodal metastases (e.g., radiologic or clinical evidence of current nodal disease)
Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm)\r\n* Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
Patients treated by BCS and sentinel lymph node biopsy (SLNB) alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm)\r\n* Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node (macrometastases, > 2 mm)\r\n* Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
Patients must have measurable disease; must have at least one non-nodal lesion
Nodal disease as detected by clinical exam or CT
Symptomatic nodal disease, i.e. scrotal, penile or leg edema
Regional nodal irradiation is part of the treatment plan
No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
Indications for comprehensive regional nodal irradiation
Patients with local or regional nodal disease are eligible
Clinical stage > T2b or evidence of nodal
Patients with local or regional nodal disease are eligible
Patients with nodal disease or distant metastatic disease
Subjects will have had standard care computed tomography (CT), MRI, or ultrasound, and a fine-needle aspiration biopsy demonstrating PTC or MTC with nodal metastases or recurrent/persistent nodal disease in a patient with known PTC or MTC
Bulky disease (defined as a nodal mass measuring >= 10 cm by CT)
Mediastinal nodal metastases (N2) disease must be confirmed histologically
Negative nodal basin clinical exam
Subject must be candidate for intralesional therapy administration defined as one or more of the following: i. at least 1 injectable cutaneous, subcutaneous, or nodal SCCHN tumor ? 10 mm in longest diameter ii. multiple injectable cutaneous, subcutaneous, or nodal SCCHN tumors that in aggregate have a longest diameter of ? 10 mm Note: Mucosal surfaces of tumor lesions and visceral metastases should not be injected.
Women without histologic confirmation of nodal involvement
No evidence of distant metastases
Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded
No evidence of distant metastases
Patients must have no clinical or radiological evidence of distant metastases (M0)
Presence of distant metastatic disease
Distant metastases
Patients with distant metastatic disease
Have evidence of a distant metastatic disease
No evidence of local recurrence or distant metastases
Patients cannot have distant metastases and have to be candidates for curative re-irradiation
Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax
Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
Evidence of distant metastases of stage IV
Documented evidence of distant metastases
Prostate cancer:\r\n* Distant metastases\r\n* Lymph node metastases
Has distant metastatic disease on imaging or staging laparoscopy at the time of study entry
Presence of distant metastatic disease
Documented evidence of distant metastases
Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
Distant metastases (M1 disease)
Unequivocal demonstration of distant metastases (M1 disease)
Evidence of distant metastases as determined by the central reading committee
Evidence of distant metastatic disease
Unresectable primary tumor or regional disease or distant metastases
Stage 3 or 4 disease without evidence of distant metastases
Clinical or pathologic evidence for distant metastases
Clinical or pathologic evidence for distant metastases
Documented distant metastatic disease
Documented evidence of distant metastases
Evidence of distant metastases
No evidence of distant metastases
Evidence of distant metastases on any staging or imaging modality
Patients with known synchronous distant metastatic disease
Patients with distant organ metastases will not be included in this study
Patients with any evidence of distant metastases
Distant metastatic disease
Distant metastases
Evidence of distant metastases
MAIN STUDY COHORT EXCLUSION CRITERIA: Evidence of nodal or distant metastases
Presence of distant metastatic (M1) disease
Evidence of distant metastases
No evidence of distant metastases
Presence of distant metastatic disease
The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete cytoreduction as indicated by:\r\n* Evidence of distant hematogenous metastatic disease or distant nodal metastases\r\n* Evidence of parenchymal hepatic metastases\r\n* Evidence of clinical, biochemical or radiological biliary obstruction\r\n* Evidence of gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity which limits ability to obtain complete cytoreduction
Evidence of distant metastases
No evidence of distant metastatic disease
Clinical evidence of regional, intransit ,or distant metastases
No known local regional or distant metastatic disease
Documented evidence of distant metastases
Evidence of distant metastases or distant leptomeningeal metastases at the time of diagnosis
Evidence of distant metastases
Evidence of distant metastases (excluding para-aortic nodes)
Patient with distant metastases
History and/or clinical evidence of distant metastases (M1)
Evidence of distant metastases (below the clavicle) by clinical or radiographic measures.
Stage 3 or 4 disease without evidence of distant metastases
No evidence of distant metastases
No evidence of distant metastases and measurable disease (> 1.5 cm).
Patients with any evidence of distant metastases
Presence of distant metastatic disease or disease not amenable to radiation treatment
Has known distant metastases; clinically involved pelvic nodes (N1-N3) are allowed
No evidence of distant metastatic disease
Clinical evidence of local recurrence or distant metastases; Note: all patients must have either a positron emission tomography (PET)/computed tomography (CT) or a CT of chest, abdomen and pelvis and a bone scan; if one or more of these is concerning for distant metastases, follow-up imaging and/or biopsy should be performed to rule out distant metastases prior to randomization
Patients with distant bone metastases at original diagnosis or relapse (patients with only skip lesions will be eligible)
Distant metastases
Evidence of distant metastatic disease (i.e. lung, liver, bone, brain, etc.)
Evidence of distant metastases or histologically or cytologically proven lymph node metastases
Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
Patients with distant metastatic disease (stage IVC)
Distant metastases
Patients with known distant metastases
Documented evidence of distant metastases
Evidence of distant metastases
Distant metastases (stage IV C, any T, any N and M1)
Evidence of distant metastatic disease
Evidence of distant metastases (M1)
Clinical evidence of distant metastases per practice guidelines for breast cancer;
Evidence of distant metastatic disease (Masaoka stage IVB)
Isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.
No indication of distant metastases
Distant metastases (M1 disease).
No direct evidence of regional or distant metastases after appropriate staging studies;
Presence of distant metastases
Documented distant metastatic disease; NOTE: pelvic lymphadenopathy is NOT excluded
Patient has evidence of distant metastases
History or current radiographic or pathologic evidence of distant metastases
Documented distant metastatic disease
Evidence of distant metastases or histologically or cytologically proven lymph node metastases
Any distant metastatic disease
Distant metastatic disease, including known brain metastases
Any evidence of distant metastases (M1)
Unequivocal demonstration of distant metastases (M1 disease)
Patients with distant metastatic disease (M1c) will not be eligible for this study
Distant metastatic disease not limited to peritoneum: solid organ metastases (liver, central nervous system, lung)
Any distant metastatic disease visualized on preoperative imaging:\r\n* Solid organ metastases\r\n* Clear radiologic evidence of carcinomatosis
No distant metastases
Tumors considered to be unresectable due to local advancement include an absence of distant metastases as well as:
Stage 3 or 4 disease without evidence of distant metastases
Patient must not have known distant metastatic disease at presentation
Evidence of distant metastatic disease.
Documented distant metastatic disease; but pelvic lymphoadenopathy is NOT excluded
Radiographic evidence of regional or distant metastases with suspected tumor in an area that is safe to biopsy
Patients who require radiotherapy to distant metastases during induction systemic therapy are eligible
Patients with distant metastases
No history of distant metastases.
Evidence of distant disease or histologically-proven nodal metastases; patients with radiologic evidence of lymphadenopathy must have biopsy proof of N0 status
Evidence of distant metastases
Evidence of distant metastases (below the clavicle) by clinical or radiographic examination
Prior or current evidence of any metastatic involvement of any distant site
Evidence of distant metastases
Tumors considered to be unresectable due to local advancement include an absence of distant metastases as well as:
Documented evidence of distant metastases or brain metastases
Has distant metastatic disease on imaging or staging laparoscopy at the time of study entry
No evidence of distant metastatic disease
Patients with evidence of distant metastatic disease
Have distant metastases
Patients with known distant metastases or other malignancies
Patients with widespread metastatic disease (> 3 distant metastases); patients with oligometastatic disease (=< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (RT) with or without chemotherapy
Distant metastases
Radiologic evidence of distant disease
Patients with evidence of distant metastatic PDAC
Distant metastatic disease at the time of enrollment
Has distant metastases
Patients with known distant metastases or other malignancies
Patients who have prostate cancer with distant metastases
Known distant metastatic disease
No indication of distant metastases (M0)
Patients have no clinical evidence of distant metastatic disease
Distant metastases
Have regional or distant metastatic disease
Clinically distant metastatic disease, either M1a/M1b/M1c
Direct evidence of regional or distant metastases after appropriate staging studies
Patients with distant metastatic disease will be eligible if they satisfy all other conditions
The patient has known distant metastatic disease
Subjects with any evidence of distant metastases
Patients with distant metastatic disease (cM1) or a life expectancy of less than 5 years
No evidence of residual cancer or metastasis after surgery
Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging\r\n* Patients with locoregionally confined disease are not eligible
Patients with evidence of clinical T4b (unresectable) or M1 (distant metastasis) according to the AJCC 2010 staging system will be ineligible
Patients with distant metastasis (e.g. spread to distant areas outside the regional lymph nodes, clearly non contiguous areas of bone involvement, or distant metastasis to lung, brain, liver or other visceral organs) are ineligible
Known evidence of distant metastasis.
Any known nodal (N1) or distant metastasis (M1)
Distant metastasis
Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
Evidence of distant metastasis (M1) involvement.
Any evidence of metastasis to distant organs (liver, lung, peritoneum)
No evidence of distant metastasis either prior to or after induction chemotherapy.
No distant metastasis as verified by one of the study investigators
Distant metastasis or adenopathy below the clavicles
Evidence of distant metastases or lymph node metastasis (es) that was not within the radiation field
Barcelona Clinic Liver Cancer (BCLC) D = patients with distant metastasis
Distant metastasis or adenopathy below the clavicles
Patients with evidence of liver metastasis are excluded
Distant metastasis
Histologically (archival tissue) confirmed adenocarcinoma of the rectum that begins within 12 cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy with no evidence of distant metastasis
No evidence of distant metastasis either prior to or after induction chemotherapy
Evidence of distant metastasis
Distant metastasis to the lung, bone or brain; typically, most stage 4 uterine papillary serous cancer (UPSC) is confined to the abdomen on presentation
Any evidence of metastasis to distant organs (liver, lung, peritoneum)
Distant metastasis
Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
Evidence of metastasis
No evidence of distant metastasis
Evidence of distant metastasis apparent prior to randomization
Patients with distant metastasis
Patients must have pathologically-confirmed, previously untreated, stage III-IV (excluding N3 or T4) squamous cell carcinoma of the oropharynx, without evidence of distant metastasis
Definitive clinical or radiographic evidence of distant metastasis or adenopathy below the clavicles
Histological confirmation of recurrence of chest wall with or without distant metastasis disease
Has local or distant metastasis
Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
Any evidence of lymph node or distant metastasis.
Patients with any distant metastasis (liver, lung, bone, brain)
No evidence of distant metastasis either prior to or after induction chemotherapy
REGISTRATION EXCLUSION CRITERIA: Evidence of distant metastasis present by CT scan, bone scan, or physical exam
Radiographic evidence of regional or distant metastasis at the time of study enrollment or at the time of diagnosis
No clinical, radiographic or other evidence of distant metastasis
Patients with distant metastasis and life expectancy >= 3 months are eligible
Cannot have distant metastasis (M0)
Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
Prior radiation to site(s) of distant metastasis of bone
Have confirmed distant metastasis with or without local recurrence
Patients with metastatic BCC, histologic confirmation of distant BCC metastasis
At least 2 organs involved in metastatic gastric tumor (including at least lung or liver or both) in addition to the site of primary tumor, where metastasis in distant lymph nodes, peritoneal metastasis, and malignant pleural effusion may count as \organs\ in this context
No evidence of distant metastasis either prior to or after induction chemotherapy
Evidence of distant metastasis on upright chest X-ray (CXR), CT or other staging studies
Evidence of distant metastasis
Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy. Note: Histologic confirmation of metastatic disease is not required.
Metastatic disease, including lymph nodes or distant metastasis
No evidence of distant metastasis representing stage IV metastatic disease
History of histologically or cytologically proven breast cancer at stage I, II and III, without evidence of distant metastasis
History of histologically or cytologically proven breast cancer at stage I, II and III without evidence of distant metastasis
Evidence of metastasis
Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
Evidence of peritoneal or distant metastasis on preoperative imaging
Evidence of metastasis