[c09aa8]: / clusters / final9knumclusters / clust_2022.txt

Download this file

154 lines (153 with data), 24.1 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
Participants who have received any other investigational agents within the 4 weeks prior to enrollment; concurrent radiation therapy is not permitted, except palliative (limited-field) radiation therapy, if all of the following criteria are met:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion
Patients may not have had any prior systemic treatment for this malignancy (for example chemotherapy or somatostatin analogues); prior palliative radiation is permitted but radiated lesions may not be used for measurement
Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)
Participants receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used); the patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with olaparib and temozolomide
Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry; Note: patients with an indication for craniospinal radiotherapy (i.e., extensive leptomeningeal disease) but have refused palliative craniospinal radiotherapy are eligible
Prior palliative radiotherapy must have been completed at least 2 weeks prior to study entry
Palliative radiotherapy within 14 days before initiation of study treatment
Any major surgery, chemotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed >= 2 weeks); concurrent hydroxyurea is allowed if less than or equal to 2 grams daily and on stable dose for >= 14 days prior to study entry
Prior palliative radiation must have been completed at least 2 weeks prior to study entry
Participants who received prior non-central nervous system (CNS) directed palliative radiation therapy within 7 days of the date of study entry
Palliative radiation therapy may have been received but not within the 30 days prior to study treatment
Concurrent use of hypoglycemic agents or any systemic therapy for melanoma; palliative limited-field radiation therapy will be allowed
Prior treatment with systemic radiopharmaceuticals (e.g., radium-223 and strontium-89). Radiopharmaceuticals for the purpose of imaging are permitted. Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to Cycle 1, Day 1.
Completed palliative radiotherapy within 7 days of the first dose of study drug.
XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.
Radiotherapy within 4 weeks prior to therapy except palliative radiation to target organs other than primary tumor may be allowed up to 2 weeks prior to registration
Radiation therapy (palliative setting is allowed.): ?4 weeks
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Is eligible for palliative radiotherapy as determined by the treating radiation oncologist.
Lesion that is amenable to palliative radiotherapy
At least 2 weeks after any prior palliative radiation (e.g. to focal metastatic lesion such as bone metastases) and recovery to =< grade 1 treatment-related toxicity
Radiotherapy: ?4 weeks (patients who receive palliative radiation for nontarget tumour lesions need not be subjected to this washout period and can be enrolled immediately)
Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been completed at least 2 weeks prior to treatment; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment
Patients who had undergone any palliative radiation within 2 weeks of study enrollment
Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Subjects who had major surgery or radiation therapy within 4 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass.
Subjects must have progression within 6 months of platin exposure during definitive or palliative therapy.
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment initiation
If palliative radiotherapy administered, completion of palliative radiation therapy must be >= 2 weeks prior to cycle 1 day 1 of protocol therapy
At least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2)
Prior palliative radiotherapy must have been completed at least 2 weeks prior to registration; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of randomization are strongly encouraged to receive palliative radiotherapy prior to randomization
Subjects requiring palliative radiation therapy at presentation
Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion
No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Participants who have had chemotherapy other than R-EPOCH or R-CHOP, or radiotherapy other than palliative radiation for medical emergencies (like cord compression), within the last 4 weeks
Emergent need for palliative radiation
Palliative surgery and/or radiation treatment within 28 days prior to course 1 day 1 (C1D1) \r\n* Localized therapy of non-target lesions is allowed
Prior definitive radiation therapy must have been completed at least 4 weeks before study drug administration; prior palliative radiotherapy should be completed at least 2 weeks before study drug administration; whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS) and focal radiation to the sites of pain or bronchial obstruction will be considered palliative; no radiopharmaceuticals (strontium, samarium) within 8 weeks before study drug administration
Need for urgent palliative intervention (e.g., impending herniation)
Prior systemic therapy, radiation therapy, or surgery within the 28 days of starting study treatment; palliative radiotherapy to a limited filed or palliative cryoablation is allowed after consultation with the principal investigator, at any time during the study participation including screening
Radiation therapy for treatment of the primary tumor within 6 weeks of cycle 1, day 1; patients who have received palliative radiation to a single site and recovered are eligible
Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study treatment;
Radical radiotherapy to the thorax with curative intent within 28 days of initiation of study drug treatment; palliative radiotherapy for bone lesions outside of the thorax or brain within 14 days of the first dose of study treatment; palliative radiotherapy to the brain or thorax within 28 days of the first dose of study drug treatment
Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study treatment; the patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug
Have had palliative radiation or biological cancer therapy within 2 weeks prior to the first dose of study drug
Patients must have histologically or cytologically confirmed advanced, incurable cancers of the esophagus, liver, stomach, small bowel, pancreas, bile duct, colon or rectum and be eligible to receive chest, abdominal and/or pelvic radiation therapy (RT) for palliation; documentation of this is required in physician note; concomitant systemic therapy is not allowed during administration of palliative RT; palliative RT can be considered for advanced primary tumors or metastatic disease as above
Radiotherapy within 4 weeks prior to enrollment, except as follows:\r\n* Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to enrollment, and\r\n* Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor-investigator prior to enrolling
Patient must be 4 weeks off any palliative radiation or craniospinal radiation
Metastatic cancer requiring palliative radiation therapy
Palliative radiation is allowed to sites that will not be used to measure response during this study
XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.
Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
Localized palliative radiation therapy is allowed for symptom management if completed >= 14 days prior to randomization
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Any radiotherapy within 3 weeks except palliative stereotactic body radiation therapy (SBRT) within 2 weeks
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
Radiotherapy (except for palliative reasons) the previous two weeks before.
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier; patients who have had prior pelvic radiation may be at increased risk for bowel perforation, and therefore may not have residual inflammatory disease of the bowel or residual bowel toxicity based on baseline imaging and clinical assessment; palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:\r\n* Repeat imaging demonstrates no new sites of bone metastases\r\n* The lesion being considered for palliative radiation is not a target lesion\r\n* Bowel toxicity is not expected from the target field due to increased risk of perforation
Palliative radiotherapy (? 10 fractions) within 2 weeks prior to Screening
Palliative radiotherapy for bone metastases < 2 weeks prior to cycle 1, day 1
Prior palliative radiation therapy to bony metastases is allowed; there should be a minimum of 14 days between the end of radiation treatment and start of study treatment
Subjects who received palliative radiotherapy ?2 weeks of study drug initiation.
discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
Prior palliative radiation therapy to bony metastases will be allowed; there should be minimum of 14 days between the end of radiation treatment and start of study treatment
Palliative radiation therapy to bony metastases </= 2 weeks before study treatment
Completed palliative radiotherapy within 7 days of the first dose of study medication.
Palliative radiation therapy within 2 weeks of Day 1 of trial drug treatment
Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or
Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
Surgery or definitive radiation within the four weeks prior to D1 of treatment under this protocol (there is no restriction on timing of palliative radiation)
No prior palliative chemotherapy
Presence of metastatic disease that, in the opinion of investigators, would require palliative treatment within 4 weeks of enrollment
Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
Prior palliative radiotherapy to metastases
There should also be a minimum of 4 weeks from any prior radiotherapy except for palliative bone directed therapy
Palliative radiation must have been completed 2 weeks prior to the initiation of study therapy.
At least one tumor for which palliative RT is considered appropriate standard therapy
At least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2)
Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy (except palliative radiation therapy for disease-related pain with a consult with the sponsor's medical monitor) within ?2 weeks of first study treatment.
Patients who have received palliative radiotherapy within 4 weeks of study entry.
Radiation oncologist determines that the patient is medically able to undergo palliative radiation therapy and plans to treat the patient’s target lesions with one fraction of high dose palliative radiation therapy utilizing the Scan-Plan-Quality Analysis (QA)-Treat STAT RAD workflow
Palliative radiation within 2 weeks.
Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
Radiotherapy, chemotherapy or immunotherapy within 4 weeks, or palliative radiation to bone metastases within 14 days of administration of cycle 1, day 1
Palliative radiotherapy must have been discontinued 1 week prior to treatment in this study
No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Prior palliative radiation therapy to bone sites is allowed as long as it is completed more than two weeks ago
Rapidly progressing cancer likely to require palliative systemic intervention within 8 weeks after study entry
Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ? 2 weeks);
Patients receiving palliative radiation will be eligible after a wash-out period of 2 weeks between finishing radiation and initiation of study drugs; palliative radiation will not be allowed during cycle 1 of treatment but is permitted in this study during following cycles as long as there are evaluable lesions that are not being irradiated
No radiotherapy within 2 weeks: exception: patients may receive palliative low dose radiotherapy (30 Gy or less) for lesions outside the lung at the discretion of the treating physician; palliative radiotherapy could be given before aerosol treatment is started if necessary
No concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
At least one measurable site of disease (>= 1.5 cm) outside of the planned palliative radiation therapy field
Women with planned treatment of palliative radiotherapy
Palliative radiation to bony metastases within 2 weeks prior to initiation of ipatasertib
Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
Patients may receive palliative radiation therapy before or during treatment on protocol, provided that there is measurable or evaluable disease out of the radiation field; patients may receive palliative radiation therapy, if needed, 48 hours after last dose of investigational drug; in addition patients may be enrolled on trial seven days following palliative radiation; we will closely monitor for the appearance of radiation recall reactions; hormonal therapy may continue in patients who have been on such treatment for three months or longer
Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been completed at least 2 weeks prior to enrollment; subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of enrollment are strongly encouraged to receive palliative radiotherapy prior to enrollment
Palliative radiation therapy within 2 weeks of Day 1, or within 4 weeks of Day 1 if a radionuclide was utilized.
Palliative radiotherapy is allowed up to 2 weeks before the first RO6927005 infusion; palliative 8 Gy radiotherapy is allowed during therapy.
Patients cannot receive concomitant radiation therapy at enrollment; while on protocol limited palliative radiotherapy extending over a small bone marrow field (10%) is allowed
Localised palliative radiotherapy Prior chemotherapy must be > 6 months before screening
Palliative radiation, including whole brain radiation therapy (WBRT), is allowed prior to enrollment as long as it is completed > 2 weeks from initiation of study treatment, and provided patient has recovered from treatment toxicities to =< grade 1
Palliative radiation to bone metastases within 2 weeks prior to Day 1
Palliative radiotherapy within 2 weeks prior to first dose of study-drug treatment in Cycle 1
An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
Palliative surgery or radiotherapy.
Received palliative/focal radiotherapy within 2 weeks of first dose of study treatment.
Prior radiation therapy completed < 3 weeks or single fraction of palliative radiotherapy < 14 days prior to first dose of KPT-330 (selinexor)
Palliative radiation therapy to metastatic sites of disease < 2 weeks prior to study day 1.
within 2 weeks prior to the first dose of KTN3379 in the case of palliative radiation therapy.
Palliative surgery and/or radiation treatment less than 4 weeks to randomization.
Palliative radiation within 2 weeks prior to Day 1.
An immediate need for palliative radiotherapy or systemic corticosteroid therapy
Therapeutic or palliative radiation therapy within 30 days of starting treatment
Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Received local palliative radiation therapy <14 days prior to the first dose of study medication
Palliative radiotherapy is not permitted throughout the study period;
No concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible
Prior systemic therapy, radiation therapy, or surgery within 28 days of starting study treatment; palliative radiotherapy to a limited field or palliative cryoablation is allowed after consultation with the principle Investigator, at any time during the study participation including screening
Palliative radiation treatment (e.g., pain control, bony lesions at risk of fracture) completed =< 2 weeks of starting study treatment; patient will be eligible if palliative radiotherapy is completed > 2 weeks from the start of study treatment and has recovered from radiotherapy toxicities
All patients must have completed any prior chemotherapy, targeted therapy, radiotherapy (unless palliative doses which must be discussed with study principal investigator), and surgery, >= 28 days before study entry
Undergoing only palliative (not curative) radiation treatment
Patients already receiving palliative care
PATIENT EXCLUSION: Palliative performance scale rating < 40
Palliative surgery and/or radiation treatment within 30 days prior to date of screening visit.
New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
Patients already receiving palliative care
(Physician participation) a palliative medicine specialist
Palliative Performance Scale (PPS) of 60 or higher at recruitment
Patient is planned to receive hypofractionated palliative radiation =< 10 fractions
Previous radiotherapy or palliative surgery to the painful site that is planned for treatment
Receiving palliative radiation therapy
At least 28 days since the last chemotherapy or immunotherapy prior to the first dose; at least 14 days since the last radiation prior to the first dose (exception: palliative radiotherapy for pain can be used greater than or equal to (>=) 7 days prior to or after infusion)
At the time of day 1 of the study, patients must have completed chemotherapy, targeted therapy, investigational therapy, other immunotherapy, radiation therapy or major surgery (requiring general anesthesia) at least 28 days before administration of the first dose of nivolumab; patients undergoing minor surgical procedures and biopsies that do not require general anesthesia may begin receiving study therapy if sufficiently recovered as determined by the treating investigator; patients may have received prior focal radiotherapy for palliation of an isolated site of disease, which must be completed at least 14 days prior to day 1 of the study; palliative (limited-field) radiation therapy is permitted during treatment with study drug(s), if all of the following criteria are met: \r\n* The lesion being considered for palliative radiation is not a target lesion\r\n* Radiation treatment is administered 12 weeks or greater after their first dose of study drug
Have had palliative radiation or biological cancer therapy within 2 weeks prior to the first dose of study drug
Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) =< 3 weeks prior to study drug administration date
Treatment with palliative or pre-operative radiation
Patient receiving palliative radiation therapy (defined as less than 45 Gy)
Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non- central nervous system (CNS) disease with medical monitor approval.
>1 week since palliative RT
Patients treated with radiation for palliative intent
Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment to the site of bone and other metastasis.
Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment.