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Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
 
Region Sponsors
California - Northern
ECOG-ACRIN Cancer Research Group
 
Acronym KP IRB No.
CN-06LFehr-15-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adenocarcinoma of the Rectum; Stage II Rectal Cancer; Stage III Rectal Cancer;
 
Purpose
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria: T3, N+, M0. T3, N0, M0. T4, N0, M0. Any T, N1-2, M0
  • T4, N0-2, M0 disease must meet 1 of the following criteria: Clinically fixed tumor on rectal examination with tumor adherent to the pelvic sidewall or sacrum. Hydronephrosis on Computed Tomography (CT) scan or Intravenous Pyelogram (IVP). Ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy. Invasion into prostate. Vaginal or uterine involvement.
  • Must have undergone complete tumor resection >= 28 days ago and able to begin treatment by day 56
  • Must have undergone concurrent neoadjuvant chemoradiotherapy* NOTE: *Neoadjuvant chemoradiotherapy received on protocol NSABP-R-04 allowed provided it met these criteria
  • Must have undergone prior radiotherapy at 40-55.8 Gy** AND received 1 of the following chemotherapy regimens: Continuous infusion of fluorouracil with or without oxaliplatin
  • fluorouracil and leucovorin calcium. Capecitabine with or without oxaliplatin. Capecitabine with or without oxaliplatin OR a continuous infusion of fluorouracil with or without oxaliplatin received on protocol NSABP-R-04. NOTE: **Intensity-modulated radiotherapy allowed
  • ECOG performance status 0-1
  • Platelet count >= 100,000/mm^3
  • Absolute granulocyte count >= 1,500/mm^3
  • Bilirubin normal (unless chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin)
  • Alkaline phosphatase (AP) < 2.5 times upper limit of normal (ULN) and aspartate aminotransferase (AST) < 1.5 times ULN
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • Pregnant or nursing
  • Evidence of metastatic disease on the surgical/intraoperative examination
  • Evidence of metastatic disease confirmed by CT scan, Magnetic resonance imaging (MRI), or ultrasound of the liver or chest CT scan or chest x-ray within the past 6 months
  • Evidence of tumor outside of the pelvis, including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy Concurrent major surgery
  • Active bleeding not related to the primary rectal tumor within the past 6 months
  • Active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy
  • Active gastroduodenal ulcer determined by endoscopy
  • Serious or nonhealing wound, skin ulcer, or bone fracture
  • Clinically significant peripheral sensory or motor neuropathy >= grade 2 Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study treatment including, but not limited to, any of the following: New York Heart Association class III or IV congestive heart failure. Concurrent symptomatic arrhythmia.
  • Transient ischemic attack or cerebrovascular accident
  • Arterial thromboembolic event, unstable angina, or myocardial infarction within the past 12 months
  • Significant peripheral vascular disease
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study requirements
  • Significant traumatic injury within the past 28 days
  • Known allergy to platinum compounds
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Rectal Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Valley-Stockton
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Tatjana Kolevska, MD
Contact Information:


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