Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III A… (NCT00003652) | Clinical Trial Compass
CompletedPhase 3
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
France350 participantsStarted 1999-01-04
Plain-language summary
RATIONALE: 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 with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.
Who can participate
Age range0 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven nonmetastatic anal cancer
* Anal/rectal junction OR
* Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction
* Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR
* Cloacogenic cancer
* Stage II or III
* T2 at least 4 cm OR
* T3 OR
* T4, N0-3, M0 OR
* T1, N1-3 OR
* T2 (less than 4 cm), N1-3
* Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound
* No prior surgery to remove tumor
PATIENT CHARACTERISTICS:
Age:
* 80 and under
Performance status:
* WHO 0 or 1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 11 g/dL (transfusion allowed)
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No cardiac condition contraindicating use of fluorouracil
Other:
* No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast
* No other serious medical or psychological condition
* No serious immunosuppression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* No prior endocrine therapy
Radiotherapy:
* No prior pelvic or inguinal radiotherapy
Surgery:
* See Disease Characteristics
* No prior …