Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

Launched by UNIVERSITY HOSPITAL BIRMINGHAM · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III (muscle invasive) bladder cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior neoadjuvant chemotherapy (yes vs no), and intent to enter only 1 of the possible 2 randomizations on study (yes vs no). Patients are randomized to one of two treatment arms.

* Arm I: Patients undergo standard radiotherapy once daily 5 days a week for 4 or 6.5...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed invasive bladder cancer (T2-4a, N0, M0)
• • Adenocarcinoma
• • Transitional cell carcinoma
• • Squamous cell carcinoma
• • Localized muscle invasion by surgery or imaging
• PATIENT CHARACTERISTICS:
• Age:
• • 18 and over
• Performance status:
• • WHO 0-2
• Life expectancy:
• • Not specified
• Hematopoietic:
• • WBC greater than 4,000/mm\^3
• • Platelet count greater than 100,000/mm\^3
• Hepatic:
• • Bilirubin less than 1.5 times upper limit of normal (ULN)
• • ALT or AST less than 1.5 times ULN
• Renal:
• • Glomerular filtration rate greater than 25 mL/min
• Other:
• • Not pregnant
• • Negative pregnancy test
• • Fertile patients must use effective contraception
• • No inflammatory bowel disease
• • No other prior malignancy within the past 2 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
• • No other prior malignancy or uncontrolled systemic disease that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Not specified
• Chemotherapy:
• • Not specified
• Endocrine therapy:
• • Not specified
• Radiotherapy:
• • No prior radiotherapy to the pelvis
• Surgery:
• • See Disease Characteristics
• • No bilateral hip replacements
• Other:
• • No concurrent metronidazole during fluorouracil administration