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)
N/A
75 Years
Both
Bladder Cancer
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michel Bolla, MD
Investigator Role:
Study Chair
Investigator Affiliation:
CHU de Grenoble - Hopital de la Tronche
Authority:
United States: Federal Government
Study ID:
EORTC-22971
NCT ID:
NCT00003642
Start Date:
October 1998
Completion Date:
Related Keywords:
- Bladder Cancer
- stage II bladder cancer
- stage III bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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