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

NCT ID: NCT00003642

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31

Brief 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.

Detailed 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.

Conditions

Bladder Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Bolla, MD

Role: STUDY_CHAIR

CHU de Grenoble - Hopital de la Tronche

Locations

Institut Bergonie

Bordeaux, , France

CHR de Grenoble - La Tronche

Grenoble, , France

Dr. Bernard Verbeeten Instituut

Tilburg, , Netherlands

Countries

France; Netherlands

References

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 patients with muscle invasive transitional cell carcinoma of the bladder. Acta Oncol. 2008;47(5):937-40. doi: 10.1080/02841860801888799.

Reference Type: RESULT

PMID: 18568488 (View on PubMed)

Other Identifiers

EORTC-22971

Identifier Type: -

Identifier Source: secondary_id

EORTC-22971

Identifier Type: -

Identifier Source: org_study_id