Colorectal Cancer
- A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
- A Phase III Trial of Irinotecan/5FU/Leucovorin or Oxaliplatin/5FU/Leucovorin with Bevacizumab, or Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
Eligibility Criteria (Per Protocol dated 04/25/09):
- Subject must have a diagnosis of adenocarcinoma of the rectum obtained by a biopsy technique which leaves the major portion of the tumor intact.
- The interval between the initial diagnosis of rectal adenocarcinoma and randomization must be no more than 42 days.
- The tumor must be either palpable by digital rectal exam or be accessible via a proctoscope or sigmoidoscope.
- Distal border of the tumor must be located less than 12 cm from the anal verge.
- The tumor must be considered by the surgeon to be amenable to curative resection (note that curative resection can include pelvic exenteration).
- Subject will NOT be eligible if there has been any therapy for this cancer prior to randomization.
- Subject will not be eligible if there is a history of invasive rectal malignancy, regardless of disease-free interval.
- Not eligible if there is evidence of metastatic disease.
- Not eligible if there is synchronous colon cancer.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.
A Phase III Trial of Irinotecan/5FU/Leucovorin or Oxaliplatin/5FU/Leucovorin with Bevacizumab, or Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Eligiblity Criteria (Prot dated 09/15/08):
- Locally advanced metastatic colorectal cancer.
- No prior systemic treatment for advanced or metastatic colorectal is allowed.
- Subjects must not have had prior radiotherapy to greater than 25% of bone marrow.
- Subject should have completed any major surgery at least 4 weeks from registration.
- No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
- No known central nervous system metastases or carcinomatous meningitis.
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- Subject must not have an uncontrolled seizure disorder, or active neurological disease.
- Subject must not have current congestive heart failure.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.