Surgery Plus Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Urinary Tract
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining surgery with chemotherapy and radiation therapy may be an effective way to treat
      cancer of the urinary tract.

      PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and
      radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of
      the urinary tract .
    

Detailed description: 
      OBJECTIVES: I. Assess the quality of life of patients with invasive stage II, III, or IV
      carcinoma of the urothelium treated with conservative surgery plus cisplatin, fluorouracil,
      and radiotherapy. II. Determine the efficacy of this regimen, in terms of local control, in
      these patients. III. Determine survival of patients treated with this regimen. IV. Determine
      the toxic effects of this regimen in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (T2-4a,
      N0, M0; potentially resectable; no contraindication to surgery vs T2-4b, N0 or N1 or pN1, M0;
      refused surgery or medical contraindications to surgery). (Accrual for stratum I was
      completed as of 10/23/2001.) Stratum I (resectable disease): Regimen A: Patients undergo
      radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously
      and cisplatin IV continuously on days 1-4 during weeks 1 and 4. If complete response is
      achieved by week 5, patients proceed to regimen B. If partial response or progression is
      observed, patients undergo cystectomy. If cystectomy is refused, patients proceed to regimen
      B. Regimen B: Patients undergo radiotherapy 5 days a week for 2 weeks. Patients also receive
      fluorouracil and cisplatin as in regimen A on weeks 2 and 5. (Accrual for stratum I was
      completed as of 10/23/2001.) Stratum II (unresectable disease): Patients undergo radiotherapy
      5 days a week for 7 weeks. Patients also receive fluorouracil and cisplatin as in regimen A
      on weeks 1, 4, and 7. Quality of life is assessed at baseline, at 6 months, and then at 1
      year. Patients are followed at 6-8 weeks, every 6 months for 2 years, and then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 75 patients (35 for stratum I and 40 for stratum II) will be
      accrued for this study. (Accrual for stratum I was completed as of 10/23/2001.)
    

Intervention name(s): cisplatin; fluorouracil; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Fluorouracil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer; anterior urethral cancer; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter