Status:
COMPLETED
Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, eit...
Detailed Description
OBJECTIVES: * Compare the recurrence-free and overall survival of patients with resectable stage II or III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without concurren...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following stage criteria:
- Stage T3, N0-2, M0 disease meeting 1 of the following criteria:
- Invasive disease in entire circumference (circular tumor)
- Tumor fixed laterally or posteriorly to pelvic structures
- Tumor adherent to the prostate and/or seminal vesicles
- Tumor infiltration into the vaginal-rectal septum
- Tumor classified as uT3 by rectal endoscopy
- Stage T4, N0-2, M0 disease meeting 1 of the following criteria:
- Clinical or radiologic evidence of pelvic organ extension (vagina, prostate, seminal vesicles, or bladder)
- Tumor extension to the anal canal or sphincter
- Tumor classified as uT4 by rectal endoscopy
- Tumor accessible by digital rectal exam
- Resectable disease
- No distant metastases
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine \< 1.36 mg/dL
- Granulocyte count \> 2,000/mm\^3
- Platelet count \> 130,000/mm\^3
- No progressive ischemic cardiomyopathy
- No acute or chronic obstruction unless treated with diversion colostomy
- No chronic inflammation of the ileum and/or colon
- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or surgery for this cancer
Exclusion
Key Trial Info
Start Date :
April 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
762 Patients enrolled
Trial Details
Trial ID
NCT00296608
Start Date
April 1 1993
End Date
August 1 2008
Last Update
May 30 2016
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