Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Completed · Phase 1/Phase 2
Conditions studied: Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
In brief
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum
Key facts
- Study ID
- NCT00006094
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2000-07-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
- Locally advanced disease defined as any of the following:
- Fixed or immovable tumor on physical exam
- T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI
- T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI
- No distant metastatic disease
- Performance status - ECOG 0-2
- Granulocyte count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse
- No prior or concurrent evidence of neuropathy
- No history of allergy to platinum compounds or antiemetics
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior fluorouracil or platinum-based therapy for any malignancy
- No other concurrent chemotherapy
- Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)
- No prior pelvic irradiation
- No concurrent antiretroviral therapy (HAART) for HIV positive patients
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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