Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	CRC-BC2001 EU-20052, ISRCTN68324339, NCT00024349

Objectives

1. 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.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 350 patients will be accrued for this study.

Outcomes

Loco-regional disease free survival at 2 years

Disease-free survival, metastases-free survival, and late toxicity by RTOG and Lent Som toxicity scores, Bladder capacity, and patient assessed Fact-BL quality of life scores at 1 and 2 years
Acute toxicity and cystoscopic local control at 3 months, 1 year, and 2 years
Rate of salvage cystectomy
Overall survival

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 weeks. Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy.



• Arm II: Patients undergo standard radiotherapy as in arm I (without chemotherapy).

If standard radiotherapy is clearly indicated (e.g., patients with multiple tumors) patients may be randomized to standard radiotherapy with or without chemotherapy (arms I or III above). If chemotherapy is clearly contraindicated, patients are randomized to standard or reduced volume radiotherapy without chemotherapy (arms III or IV above).

Quality of life is assessed at baseline, at the end of therapy, at 6 and 12 months post-randomization, and then annually for at least 5 years.

Patients are followed at 6, 9, and 12 months post-randomization and then at least annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Trial Contact Information

Trial Lead Organizations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Nicholas James, MD, Protocol chair		Ph: 44-121-697-8314 Email: n.d.james@bham.ac.uk

Registry Information
Official Title		2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer
Trial Start Date		2001-06-01
Registered in ClinicalTrials.gov		NCT00024349
Date Submitted to PDQ		2001-07-17
Information Last Verified		2007-05-17

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