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

Alternate Title

Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	80 and under	Other	EORTC-30004 NCT00042887

Objectives

1. Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder.
2. Compare the disease-free survival of patients treated with these regimens.
3. Determine the response rate at 6 weeks in patients treated with chemoresection.
4. Determine the percent of patients with tumor at 6 weeks treated with transurethral resection.
5. Compare the quality of life of patients treated with these regimens.
6. Compare the side effects of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder
  • Ta or T1



• Tumor no greater than 2 cm in diameter



• Negative urine cytology



• No suspicious lesions in bladder requiring biopsy



• No tumors in the prostatic urethra or upper urinary tract



• No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ

Prior/Concurrent Therapy:

Biologic therapy

• More than 12 months since prior BCG vaccine

Chemotherapy

• At least 1 year since prior mitomycin

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• No prior organ transplant

Other

• At least 3 months since prior intravesical treatment

Patient Characteristics:

Age

• 80 and under

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• HIV negative
• No active intractable or uncontrollable bladder infection
• No urethral strictures that would preclude endoscopic procedures or repeated catheterization
• No prior or concurrent congenital or acquired immune deficiency syndrome
• No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix
• No prior or concurrent leukemia or Hodgkin's disease
• No concurrent disease for which general anesthesia is contraindicated
• No psychological, familial, sociological, or geographical condition that would preclude study compliance
• Not pregnant or nursing

Expected Enrollment

A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks.



• Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin.

Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6.

Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Willem Oosterlinck, MD, PhD, Study coordinator		Ph: 32-9-240-2276 Email: willem.oosterlinck@ugent.be

Registry Information
Official Title		Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 bladder Tumors: A Prospective Randomized Phase III Trial
Trial Start Date		2002-05-16
Registered in ClinicalTrials.gov		NCT00042887
Date Submitted to PDQ		2002-06-07
Information Last Verified		2004-06-10

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