Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: cisplatin; fluorouracil; paclitaxel; radiation therapy; Gemcitabine; Radical cystectomy
Intervention description: Induction: 15 mg/m2 as a 60-minute infusion on days 1, 2, 3, 8, 9, 10, 15, 16, and 17; Consolidation: 15 mg/m2 as a 60-minute infusion on days 1, 2, 8, and 9; Adjuvant: 35 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.; Induction: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 15, 16, and 17; Consolidation: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 8, 9, and 10.; Induction: 50 mg/m2 as a 60-minute infusion on days 1, 8, and 15; Consolidation: 50 mg/m2 as a 60-minute infusion on days 1 and 8; Adjuvant: 50 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.; Induction: External beam irradiation, 1.6 Gy, will be given to the pelvis in the first treatment followed by an interfraction period of at least 4-6 hours. During the second treatment, 1.5 Gy will be delivered to the whole bladder for the first five sessions (7.5 Gy) then to the tumor plus a margin for eight sessions (12. Gy). Consolidation: Consolidation therapy will start 7-14 days following a cystoscopic re-evaluation demonstrating a complete response to the induction therapy. 1.5 Gy (per fraction) will be given to the pelvis in two treatment fractions per day, with an interfraction period of at least 4-6 hours.; Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.; Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.
Intervention MeSH terms: Paclitaxel; Gemcitabine; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II bladder cancer; stage III bladder cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to
      damage tumor cells. It is not yet known which regimen of combination chemotherapy plus
      radiation therapy with or without surgery is more effective in treating bladder cancer.

      PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy
      regimens and radiation therapy with or without radical cystectomy in treating patients who
      have stage II or stage III bladder cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed operable primary muscle invasive bladder cancer

               -  T2-T4a, NX or N0, M0 (stage II or III)

          -  Must have an adequate functioning bladder

          -  Must have undergone a prior transurethral resection of the bladder tumor within the
             past 8 weeks

          -  No evidence of tumor-related hydronephrosis

          -  No evidence of distant metastases or histologically or cytologically confirmed lymph
             node metastases

          -  Patients with involvement of the prostatic urethra with transitional cell cancer that
             was visibly completely resected are allowed

               -  No evidence of stromal invasion of the prostate

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Hemoglobin at least 10 g/dL

          -  White blood cell (WBC) count at least 4,000/mm^3

          -  Absolute neutrophil count at least 1,800/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Serum bilirubin no greater than 2.0 mg/dL

        Renal

          -  Serum creatinine no greater than 1.5 mg/dL

          -  Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater
             than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion
             of the study chair

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a
             prostate cancer, or carcinoma in situ of the cervix

          -  Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical
             cystectomy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior systemic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior pelvic radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g.,
             aminoglycosides)