[c09aa8]: / clusters / 9knumclustersv2 / clust_844.txt

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Participants may not have a major surgical procedure, open biopsy, or significant traumatic injury within days prior to starting cediranib; anticipation of need for major surgical procedures during the course of the study also excludes patients from the trial
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to enrollment\r\n* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least days prior to enrollment and subcutaneous ports must be placed at least days prior to enrollment\r\n* Core biopsy within days prior to enrollment\r\n* Fine needle aspirate within days prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within days prior to start of protocol therapy
Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within days prior to study enrollment
Major surgical procedure or significant traumatic injury within weeks prior to randomization and must have fully recovered from any such procedure or injury; planned surgery (if applicable) or the anticipated need for a major surgical procedure within the next six months. Note: the following are not considered to be major procedures and are permitted up to days before randomization: Thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, and imaging-guided biopsy for diagnostic purposes
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day of treatment or anticipation of need for major surgical procedure during the course of the study
Patients who have had or are planning to have the following invasive procedures will be excluded:\r\n* Major surgical procedures, laparoscopic procedure, open biopsy, or significant traumatic injury within days prior to day therapy; subcutaneous port placement or central line placement is not considered major surgery, but must be placed greater than hours from planned day of therapy\r\n* Core biopsy within days prior to day therapy\r\n* Fine needle aspirate or central line placement within hours prior to day therapy\r\nNote: Routine bone marrow aspirate and biopsy for the purposes of disease staging are not part of these exclusion guidelines
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
Prior therapy:\r\n* Prior treatment with systemic immunosuppressive treatments, aside from systemic dexamethasone therapy for cerebral edema, such as methotrexate, chloroquine, azathioprine, etc. within months of start of study therapy\r\n* Prior treatment with interstitial brachytherapy within months of start of study therapy\r\n* Previous treatment with programmed death-protein (PD-) or programmed death-ligand (PD-L) directed therapy\r\n* Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study\r\n* Minor surgical procedure (eg, stereotactic biopsy within days of first study treatment; placement of a vascular access device within days of first study treatment)
Patients may have undergone a major or minor surgical procedure as long as the following apply:\r\n* Major surgical procedure, open biopsy or significant traumatic injury greater than days prior to the first date of study therapy\r\n* Core biopsy or intravenous (IV) port placement greater than days prior to the first date of study therapy
Patients who have had or are planning to have the following invasive procedures will be excluded- Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to Day therapy (Subcutaneous port placement or central line placement is not considered major surgery but must be placed greater than hours from planned Day of therapy); Core biopsy within days prior to Day therapy; Fine needle aspirate or central line placement within hours prior to Day therapy.
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least days prior to enrollment and subcutaneous ports must be placed at least days prior to enrollment\r\n* Core biopsy within days prior to enrollment\r\n* Fine needle aspirate within days prior to enrollment\r\n* 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 days prior to start of protocol therapy
Major surgical procedure (including open biopsy, significant traumatic injury, etc.) within days, or anticipation of the need for major surgical procedure during the course of the study as well as minor surgical procedure (excluding placement of a vascular access device or bone marrow biopsy) within days prior to randomization.
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Cycle , Day or anticipation of need for major surgical procedure during the course of the study
Invasive procedures defined as follows:\r\n* Major surgical procedure or significant traumatic injury within days prior to day therapy, or open biopsy within days prior to day therapy\r\n* Anticipation of need for major surgical procedures during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day or anticipation of need for major surgical procedure during the course of the study
Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within days prior to first study treatment, or anticipation of need for major surgical procedure during the course of the study.
History of a major surgical procedure or a significant traumatic injury within days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study.
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to the start of study drug ( days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study (except for the planned metastasectomy)
Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within days prior to registration or those patients who receive a non-central nervous system (CNS) minor surgical procedures (e.g. core biopsy or fine needle aspiration) within days prior to registration; there is no waiting period for central line placement; there is a -day window for recovery prior to registration for patients who underwent stereotactic biopsy of the brain
Patients with a major surgical procedure, open biopsy, or significant traumatic injury within 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
Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); or fine needle aspirations or core biopsies) within days prior to first dose of study drug. NOTE: Patients will be allowed to start cycle day therapy after hours from pre-treatment biopsy
Major surgical procedure with weeks of first dose of study drug; open biopsy, or significant traumatic injury within days prior to enrollment date; anticipation of need for major surgical procedure during the course of the study.
Major surgical procedure or significant traumatic injury within weeks prior to study treatment, and must have fully recovered from any such procedure; and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned within the next months (Note: The following are not considered to be major procedures and are permitted up to days prior to study treatment: Thoracentesis, paracentesis, port placement, laparoscopy, thorascopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures.)
(Bevacizumab-related exclusion) Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. For patients with brain tumors, craniotomy or intracranial biopsy sites must be adequately healed; free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of study enrollment
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to initiation of protocol therapy; there should be no anticipation of need for major surgical procedures during the course of the study\r\n* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least days prior to initiation of protocol therapy and subcutaneous ports must be placed at least prior to initiation of protocol therapy
Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within days prior to on-study date, or anticipation of need for major surgical procedure during the course of the study
Invasive surgical intervention (including biopsy by surgical route), major traumatic injury during the days prior to the start of treatment, or scheduled invasive surgical intervention during the study treatment
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day , anticipation of need for major surgical procedure during the course of the study; as an example, port placement or core biopsies are not considered major surgical procedures
No major surgical procedure or significant traumatic injury within weeks prior to study registration, and must have fully recovered from any such procedure; date of surgery (if applicable) or the anticipated need for a major surgical procedure within the next six months; Note: the following are not considered to be major procedures and are permitted up to days before therapy initiation: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within weeks prior to first dose of study drug; or anticipation of need for major surgical procedure during the course of the study (other than defined by protocol); or fine needle aspirations or core biopsies within days prior to first dose of study drug
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day or anticipation of need for major non-cranial surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day , anticipation of need for major surgical procedure during the course of the study
Invasive procedures defined as follows:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within days prior to day therapy\r\n* Anticipation of need for major surgical procedures during the course of the study\r\n* Core biopsy within days prior to day (D) therapy
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day of FOLFIRI + bevacizumab initiation or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day of study drug ( days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study
History of a major surgical procedure or a significant traumatic injury within days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study.
Major surgical procedure (including open biopsy, excluding central line intravenous (IV) and port-a-cath placement) within ? days prior to initiating study treatment, or anticipation of the need for major surgery during the course of the study treatment
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Day or anticipation of need for major surgical procedure during the course of the study
Patients who have had or are planning to have the following invasive procedures are not eligible: \r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least days prior to enrollment for external lines (e.g. Hickman or Broviac) and at least days prior to enrollment for subcutaneous port\r\n* Core biopsy within days prior to enrollment\r\n* Fine needle aspirate within days prior to enrollment\r\n* NOTE: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within days prior to start of protocol therapy
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within days prior to enrollment\r\n* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least days prior to enrollment and subcutaneous ports must be placed at least days prior to enrollment\r\n* Core biopsy within days prior to enrollment\r\n* Fine needle aspirate within days prior to enrollment\r\n* NOTE: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within days prior to start of protocol therapy
Invasive procedures defined as follows:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within days prior to day therapy\r\n* Anticipation of need for major surgical procedures during the course of the study\r\n* Core biopsy within days prior to day therapy
Patients who have a major surgical procedure, or significant traumatic injury within days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within days prior to the first date of treatment on this study
Patients with invasive procedures or anticipation of invasive procedures within the following timeframes as defined below:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within days prior to the first date of bevacizumab therapy (cycle )\r\n* Major surgical procedure anticipated during the course of the study\r\n* Core biopsy within days prior to the first date of bevacizumab therapy (cycle )
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
This criterion applies only to the patients enrolled before August , and those enrolled after this date electing to receive bevacizumab; patients who have had a major surgical procedure, open biopsy, dental extractions or other dental surgery/procedure that results in an open wound, or significant traumatic injury within days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within days prior to the first date of treatment on this study
No major surgical procedure or significant traumatic injury within weeks prior to study registration, and must have fully recovered from any such procedure; date of surgery (if applicable). Note: the following are not considered to be major procedures and are permitted up to days before therapy initiation: Thoracentesis, paracentesis, port placement, laparoscopy, thorascopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
No major surgical procedures, open biopsy or significant traumatic injury =< days prior to registration or anticipation of need for elective or planned major surgical procedure during the study; core biopsy or other minor surgical procedures =< days prior to registration
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day , or anticipated need for major surgical procedure during the course of the study, or fine needle aspirations or core biopsies within days prior to day
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Day or anticipation of need for major surgical procedure during course of the study.
The subject had a major surgical procedure, substantial open biopsy, or significant traumatic experience within days before the Day visit, or anticipation of need for major surgical procedure during the course of the study.
No major surgical procedure or significant traumatic injury within weeks prior to study registration, and must have fully recovered from any such procedure; date of surgery (if applicable). Note: the following are not considered to be major procedures and are permitted up to days before therapy initiation: Thoracentesis, paracentesis, port placement, laparoscopy, thorascopy, tube thoracostomy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study; minor surgical procedures including placement of a vascular access device, within days of the first study treatment
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Cycle , Day or anticipation of need for a major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to enrollment date, anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Day , anticipation of need for major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspirations or core biopsies within days prior to Day
Major surgical procedure, open biopsy, or significant traumatic injury =< days prior to registration (=< days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study
Patients who have a major surgical procedure, or significant traumatic injury within days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within days prior to the first date of treatment on this study
Major surgical procedure, open biopsy, or significant traumatic injury =< weeks prior to registration/randomization; (port-a-cath placement does not count as a major surgical procedure and patients can be enrolled at any time after placement)
Patients must not have experienced any major surgical procedure, open biopsy, or significant traumatic injury within days prior to registration, or be anticipated to need a major surgical procedure during the course of the study; NOTE: the exception is craniotomy; patients with brain tumors who have undergone craniotomy or intracranial biopsy must be cleared by their neurosurgeon to participate at the time of registration
Invasive procedures defined as follows:\r\n* Major surgical procedure, open biopsy or significant traumatic injury within days prior to day therapy\r\n* Brain biopsy within days prior to day of therapy (wounds must be fully healed from brain biopsies performed more than days prior to day of therapy)\r\n* Anticipation of need for major surgical procedures during the course of the study\r\n* Core biopsy within days prior to day of therapy
For patients who have had a major surgical procedure, open biopsy, or significant traumatic injury within days prior to enrollment, or anticipate the need for such while on active treatment, may participate and receive bevacizumab at the start of the second or third cycle as they would under standard care; placement of vascular access device is not considered major surgery, but the incision must have healed before initiation of treatment
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day - or anticipation of need for major surgical procedure during the course of the study; (a major surgical procedure constitutes an invasive procedure which requires general anesthetic support, hospitalization, and supportive care such as laparotomy, laminectomy, etc.)
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day of treatment or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure (including craniotomy) or significant traumatic injury less than days or those who receive minor surgical procedures (e.g. core biopsy or fine needle aspiration) within days
Major surgical procedure, open biopsy, or significant traumatic injury other than craniotomy within days prior to Day , anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within weeks before enrollment or anticipation of need for major surgical procedure during the course of the study; subjects with limited metastatic disease that has been surgically resected may enter and begin study therapy weeks after surgery and the bevacizumab containing portion of the regimen may begin no sooner than weeks after surgery\r\n* If, during the course of the study, a subject progresses on therapy to the point that surgical resection is recommended, the subject should be discontinued from the study but is eligible for re-enrollment into the study after the surgical resection provided all inclusion/exclusion criteria are met
Major surgical procedure, open biopsy, or significant traumatic injury, within days prior to day , anticipation of need for major surgical procedure during the course of the study; (minor surgical procedures, fine needle aspirations or core biopsies within days prior to day ; bone marrow aspiration +/- biopsy is allowed)
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to Day or anticipation of need for major surgical procedure during course of study
Patients may not have had a major surgical procedure, open biopsy (excluding skin cancer resection, cutaneous/subcutaneous melanoma metastasis resection or biopsy or vascular access device insertion), or significant traumatic injury within days prior to Day , or have an anticipated need for major surgical procedure or a planned elective surgical procedure during the course of the study.
Patients with contraindications to anticoagulation therapy for deep venous thrombosis such as:\r\n* Patients on full treatment dose of anticoagulation such as those patients being treated for pulmonary embolus\r\n* Presence of central nervous system or brain metastases\r\n* Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day \r\n* Anticipation of need for major surgical procedure during the course of the study\r\n* Those patients that develop DVTs during the study will be treated with anticoagulants and in certain cases, will continue on the protocol
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to randomization, or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
Major surgical procedure, open biopsy, or significant traumatic injury or anticipation of need for major surgical procedure during the course of the study; core biopsy or other minor surgical procedure, eg placement of a vascular access device, are excluded from this requirement
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
History of invasive procedures defined as follows: \r\n* Major surgical procedure, open biopsy, or significant traumatic injury =< days prior to registration\r\n* Anticipation of need for major surgical procedures during the study\r\n* Core biopsy =< days prior to registration
Major surgical procedures, or significant traumatic injury =< days prior to registration or anticipation of need for elective or planned major surgical procedure during the course of the study
Patient who has undergone the following invasive procedures: Major surgical procedure, open biopsy or significant traumatic injury < days prior to starting study drug or has not recovered from side effects of such therapy, anticipation of need for invasive surgical procedure during the course of the study, biopsy within days prior to starting study drug
Major surgical procedure, open biopsy or significant traumatic injury within days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
Patients with or with anticipation of a non-study related invasive procedure defined as followed: major surgical procedure, open biopsy or significant traumatic injury within days prior to the first date of bevacizumab; major non-study related surgical procedure anticipated during the course of the study; core biopsy within days prior to first date of bevacizumab
No excess risk of bleeding (any of the following):\r\n* Bleeding diathesis or coagulopathy\r\n* Thrombocytopenia\r\n* Major surgical procedure, open biopsy, or significant traumatic injury within the past days or anticipation of need for major surgical procedure during the course of the study\r\n* Minor surgical procedures, stereotactic biopsy, fine needle aspiration, or core biopsy within the past days
Major surgical procedure, open biopsy, or significant traumatic injury within days prior to day or anticipation of need for major surgical procedure during the course of the study