Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

A Phase II Feasibility Study of Combined Accelerated External Radiation and Chemotherapy With 5FU and CDDP Following Transurethral Resection in Patients With Muscle Invasive Transitional Carcinoma of the Bladder - T2-T3, N0, M0 (UICC 1992)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003642
• Other study ID #: EORTC-22971
• Secondary ID: EORTC-22971
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 5, 2012
• Start date: October 1998

Study information

• Verified date: March 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer, and who have undergone transurethral resection.

Description:

OBJECTIVES: I. Evaluate the rate of severe acute toxicity occurring during therapy with accelerated external radiotherapy with concurrent fluorouracil (5-FU) and cisplatin following transurethral resection of the bladder in patients with stage II or III muscle invasive transitional cell carcinoma of the bladder. II. Evaluate the rate of freedom from local recurrence to this combined therapy assessed 3 months after the end of treatment in these patients. III. Assess the feasibility of this new therapeutic approach in this patient population. IV. Determine the overall recurrent free survival, long term side effects, and overall survival in these patients.

OUTLINE: This is an open label, multicenter study. Patients undergo accelerated external radiotherapy twice daily 5 days a week for 5 weeks. Concurrent chemotherapy is administered on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil by 24 hour continuous infusion daily on days 1-5. Patients are followed at 3 months, then every 3 months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: There will be 19-43 patients accrued into this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed unifocal or multifocal transitional cell carcinoma of the bladder no greater than 5 cm, with evidence of muscle invasion documented by transurethral resection of the bladder (TURB), with no residual visible or palpable tumor mass at the end of TURB Stage II or III (T2-T3, N0, M0) No squamous cell or adenocarcinoma No evidence of pelvic lymph node involvement by CT scan or MRI No evidence of hydronephrosis No evidence of distant metastases No disease in the prostatic urethra

PATIENT CHARACTERISTICS: Age: Under 76 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: See Disease Characteristics Creatinine clearance greater than 50 mL/min Cardiovascular: No progressive ischemic cardiopathy Other: No reduced bladder capacity No prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix treated by hysterectomy

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy for superficial disease allowed No concurrent growth factors Chemotherapy: No prior systemic chemotherapy Prior intravesical chemotherapy or intravesical BCG allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: No prior surgery for bladder cancer except transurethral resection of the bladder

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	CHR de Grenoble - La Tronche	Grenoble
Netherlands	Dr. Bernard Verbeeten Instituut	Tilburg

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

France,  Netherlands, 

References & Publications (1)

Poortmans PM, Richaud P, Collette L, Ho Goey S, Pierart M, Van Der Hulst M, Bolla M; EORTC Radiation Oncology Group. Results of the phase II EORTC 22971 trial evaluating combined accelerated external radiation and chemotherapy with 5FU and cisplatin in pa — View Citation