[c09aa8]: / clusters / clustall / surgery.txt

Download this file

199 lines (198 with data), 25.4 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
Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrollment
30.0
No major surgery within 28 days prior to registration
97.0
Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 28 days prior to enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrollment
68.0
Any major surgery, extensive radiotherapy (> 15 days of treatment), chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to first dose of study treatment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to first dose of study treatment
130.0
No history of major surgery =< 14 days prior to registration
440.0
No history of major surgery =< 28 days of registration
34.0
No major surgery =< 14 days prior to registration
20.0
Patients must not have received any major surgery or immunotherapy within 28 days prior to registration
280.0
Ibrutinib must be discontinued 7 days before (when possible) until 7 days after major surgery, and 3 days before (when possible) until 3 days after minor surgery; thus, patients to be enrolled on an ibrutinib trial must have completed major surgery > 7 days before initiating treatment, and/or must have completed minor surgery > 3 days before initiating treatment
52.0
Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment; tumor biopsy is allowed
223.0
No major surgery within 21 days of registration with stabilization or resolution of surgical adverse events
110.0
No major surgery =< 7 days prior to registration and no minor surgery =< 3 days prior to registration (with the exception of intravenous access placement, e.g. Hickman or peripherally inserted central catheter [PICC])
302.0
Major surgery within 21 days of starting protocol treatment
82.0
Major surgery within 21 days of starting protocol treatment
50.0
Major surgery within 30 days prior or during the study period
46.0
No major surgery within 28 days prior to randomization
766.0
Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity (e.g. doxorubicin), biologic therapy, or immunotherapy within 21 days prior to enrollment and/or daily or weekly chemotherapy (e.g. sunitinib, sorafenib and pazopanib) without the potential for delayed toxicity within 14 days prior to enrollment
27.0
Patients must have recovered to at least a grade =< 1 toxicity eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01), or therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitors prior to entering the study; patients must be >= 2 weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase 0 study; patients must be >= 1 month since completion of any prior radiation (>= 2 weeks for palliative radiation therapy); however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy* Prior therapy with topoisomerase I inhibitors is allowed
74.0
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks (or 5 half-lives, whichever is shorter) prior to entering the study (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
140.0
Patients must have completed any chemotherapy, radiation therapy, biologic therapy, or major surgery >= 4 weeks prior to enrollment (6 weeks for nitrosoureas or mitomycin C); patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study, at the discretion of the principal investigator; patients must have recovered to eligibility levels from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous (IV) bisphosphonate treatment prior to study entry may continue this treatment
68.0
Any prior therapy must have been completed >= 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients who have had prior monoclonal antibody therapy must have completed that therapy at least 3 half-lives of the antibody or 6 weeks ago; patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center principal investigator (PI) after consultation with a cardiologist and if screening echocardiogram is normal
70.0
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study or >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events
72.0
TREATMENT: Any prior therapy, radiotherapy, or major surgery must have been completed >= 3 weeks (> 6 weeks for nitrosoureas or mitomycin C) or 5 half-lives of the agent (whichever is shorter) prior to enrollment on protocol, and the participant must have recovered to eligibility levels from prior toxicity; radiofrequency ablation (RFA) of localized lesions should have been performed >= 2 weeks prior to treatment
700.0
Patients must have completed radiation therapy or major surgery >= 3 weeks, or biologic therapy or chemotherapy >= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
24.0
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 3 weeks prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
35.0
Patients must have recovered from clinically significant toxicity of prior therapy to grade =< 1 or pre-treatment baseline; the following intervals from previous treatments are required prior to day 1 of study therapy:* 12 weeks from the completion of radiation for recurrent GBM unless there is surgical diagnosis of recurrence or a new lesion that was not previously radiated* 6 weeks from a nitrosourea chemotherapy* 3 weeks from a non-nitrosourea chemotherapy* 4 weeks from an investigational agent (not Food and Drug Administration [FDA] approved) (or 5 half lives, whichever is shorter)* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.) (or 5 half lives, whichever is shorter)
23.0
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
52.0
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 2 weeks since any prior palliative radiation or cyberknife therapy; patients must have recovered to grade 1 from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment
46.0
Any prior therapy must have been completed at least 4 weeks prior to entry into the study
36.0
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study and >= 1 week since any palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events
60.0
Patients must have recovered to grade 1 or baseline from adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy, biologic therapy, or definitive radiotherapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or 5 half-lives, whichever is shorter, prior to entering the study; palliative-intent radiotherapy (30 Gy or less) must be completed at least 2 weeks prior to start of treatment, and may not be to a lesion that is included as measurable disease; patients must be >= 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI�s) discretion, and should have recovered to grade 1 or baseline from any toxicities
38.0
Any prior therapy must have been completed >= 4 weeks or, if known, >= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least 6 weeks out from nitrosoureas and mitomycin C; prior definitive radiation should have been completed >= 4 weeks or palliative radiation should have been completed >= 2 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the principal investigator [PI]�s discretion); patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment); patients who have received more than a cumulative dose of 350 mg/m^2 of doxorubicin may be enrolled at the discretion of the coordinating center PI, with a screening echocardiogram
35.0
Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery
360.0
Patients must not have had major surgery within 6 weeks prior to enrollment on the high risk stratum; patients with history of recent minor surgical procedures (vascular catheter placement, bone marrow evaluation, laparoscopic surgery, liver tumor biopsy) will be eligible
253.0
Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
360.0
Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study
162.0
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
2580.0
Bilateral mammogram =< 90 days prior to date of surgery; Note: for patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment
265.0
Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at this time, then it should be performed at least 10 days following surgery before study enrollment; false positive cytology can occur within 10 days of surgery; Note: patients with positive CSF cytology obtained prior to 10 days after surgery may have cytology repeated to determine eligibility
275.0
Patient must consent for the appropriate surgery
600.0
The patient must have recovered from surgery with the incision completely healed and no signs of infection
1636.0
Patients with microscopic positive margins after definitive surgery
1636.0
Patients with residual macroscopic disease after surgery
252.0
Patients may have received prior surgery (for both the primary and stage IV disease); all adverse events associated with prior surgery must have resolved to =< grade 1 prior to registration
97.0
Recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access
104.0
Major surgery within 4 weeks prior to entry into the study, or a surgical incision that is not fully healed
70.0
Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines, monoclonal antibodies or major surgery in the 4 weeks prior to the start of the study
52.0
Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
700.0
Patients who are not currently candidates for radical cystectomy (e.g. patient refuses surgery, comorbidities preclude major surgery, etc.)
54.0
Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study registration
10000.0
At least 4 weeks must have elapsed since the patient underwent any major surgery (eg. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]); there is no restriction on MINOR procedures: (eg. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy)
250.0
Major surgery within 2 weeks prior to randomization: patients must have recovered from any effects of any major surgery
1500.0
Prior surgery for the IHC; (liver resection is not allowed)
182.0
The patient must have recovered from effects of surgery, postoperative infection, and other complications within 28 days prior to step 2 registration
606.0
Patients must be adequately recovered from surgery at the time of randomization
NONE
Patients must have discontinued radiation therapy prior to registering to Step 2 of the study and recovered from any adverse events associated with treatment; prior surgery must be >= 2 weeks from registration to Step 2 and patients must be fully recovered from post-surgical complications
300.0
Major surgery within 4 weeks of first dose of study drug
52.0
Patients who are less than 4 weeks post-operative (op) after major surgery
36.0
No clinically significant bleeding (i.e. gastrointestinal [GI] bleed, intracranial bleeding) within 6 months or major surgery within 4 weeks; minor surgeries (i.e. port placement, cataract surgery) are allowed within 2 weeks
66.0
Have had recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access
50.0
Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
50.0
Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
180.0
Patients must not have any unresolved wounds from previous surgery
180.0
Ibrutinib should be held at least 3 to 7 days pre- and post-surgery, depending upon the type of surgery and risk of bleeding
32.0
At least 4 weeks since major surgery or radiation therapy
70.0
Inability to safely delay surgery by 8 weeks as per surgeon�s discretion
29.0
No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
NONE
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery
53.0
Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422* Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)** Note: patients must begin treatment within 36 days of definitive surgery
45.0
Patients who are not candidates for major abdominal surgery due to known medical comorbidities
147.0
Major surgery within 4 weeks before randomization
348.0
Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay required for minor procedures (e.g., tumor fine-needle aspiration [FNA] or core biopsy, venous access device placement)
84.0
Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration
707.0
Have had recent major surgery within a minimum of 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access
24.0
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP; Note: local surgery of isolated lesions for palliative intent is acceptable
180.0
Patients must NOT have radiotherapy, or major surgery or active drug therapy for pNET (SSA permitted) within 4 weeks prior to study treatment start
40.0
Patients who have had major surgery or trauma within 28 days prior to entering the study; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment
132.0
Step 1 registration must occur within 180 days of the initial surgery; within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, step 1 registration must occur within 180 days of the initial resection
148.0
Major surgery must not have occurred within 2 weeks prior to enrollment and patients must have recovered from any effects of any major surgery
49.0
Major surgical procedures, or significant traumatic injury =< 14 days prior to registration or anticipation of need for elective or planned major surgical procedure during the course of the study
48.0
Invasive procedures defined as follows:* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy* Anticipation of need for major surgical procedures during the course of the study* Core biopsy within 7 days prior to day 1 therapy
23.0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
549.0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
680.0
Patients who have had or are planning to have the following invasive procedures are not eligible:* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment* Core biopsy within 7 days prior to enrollment* Fine needle aspirate within 7 days prior to enrollment* Surgical or other wounds must be adequately healed prior to enrollment; Note: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
67.0
A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib (percutaneous/endobronchial biopsies are allowed)
126.0
No excess risk of bleeding (any of the following):* Bleeding diathesis or coagulopathy* Thrombocytopenia* Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days or anticipation of need for major surgical procedure during the course of the study* Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past 7 days
130.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
35.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
488.0
Major surgical procedure within 28 days prior to cycle 1, day 1 and patients must have recovered from any effects of any major surgery; anticipation of need for a major surgical procedure during the course of the study
72.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
40.0
Patients who have had or are planning to have the following invasive procedures are not eligible:* Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port* Core biopsy within 7 days prior to enrollment* Fine needle aspirate within 7 days prior to enrollment* Surgical or other wounds must be adequately healed prior to enrollment* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
146.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study with the exception of the planned breast cancer surgery that is part of the trial design
60.0
A major surgical procedure, open biopsy, or significant traumatic injury within 3 months prior to cycle 1 day 1 (percutaneous/endobronchial/endoscopic biopsies are allowed)
90.0
Patients who have had or are planning to have the following invasive procedures are not eligible:* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment* Core biopsy within 7 days prior to enrollment* Fine needle aspirate within 7 days prior to enrollment* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
51.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
22.0
Invasive procedures defined as follows:* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy* Anticipation of need for major surgical procedures during the course of the study* Core biopsy within 7 days prior to day 1 (D1) therapy
98.0
Participants may not have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib; anticipation of need for major surgical procedures during the course of the study also excludes patients from the trial
70.0
Patients with a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of therapy, or anticipation of need for major surgical procedure during the course of the study other than that defined by protocol are ineligible
21.0
Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
78.0