Overview

Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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 surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNICANCER
Treatments:
Cisplatin
Fluorouracil
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV carcinoma of the
urothelium infiltrating muscle Primary OR After development of a superficial tumor T2-T4b
with or without lymph node involvement and no detectable metastases No epidermoid cancer or
adenocarcinoma No extrapelvic lymph node involvement

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: More
than 6 months Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than
100,000/mm3 Neutrophil count greater than 1,500/mm3 Hemoglobin greater than 10 g/dL
Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL Other: Not pregnant Fertile
patients must use effective contraception during and for 2 months after study No other
prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No
prior serious illness of the gastrointestinal tract (e.g., rectal bleeding or
diverticulosis with complications) No contraindication to fluorouracil, cisplatin, or
radiotherapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy except intravesicular instillations Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy Surgery: Not specified