Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery

Sponsored by National Cancer Institute (NCI)

Phase Quota
Phase 2

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different chemotherapy and radiation therapy regimens to see how they work in treating patients with stage II or stage III bladder cancer that was removed by surgery.

Study Start Date: December 2008

Estimated Completion Date: January 2018

Specialties: Urology: Bladder,Clinical Pharmacology,Oncology Oncology: Pharmacology/Therapy,Radiation Oncology,Renal/Urologic Radiology: Radiotherapy (XRT) Pharmacy: Chemotherapy/Oncology


  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: gemcitabine hydrochloride
  • Radiation: radiation therapy

Inclusion criteria


  • Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 8 weeks
    • Exhibits histological evidence of muscularis propria invasion
  • Clinical stage T2-T4a, NX or N0, M0 disease
    • TCC involvement of the prostatic urethra allowed provided it was visibly completely resected AND there is no evidence of stromal invasion of the prostate
    • No histologically or cytologically confirmed lymph node metastases
      • Radiologic evidence of lymph node positivity allowed provided the lymph node is further evaluated by lymphadenectomy or percutaneous needle biopsy AND confirmed to be negative
    • No evidence of distant metastases
  • Operable disease
    • Has undergone transurethral resection of the bladder tumor within the past 8 weeks
    • Judged to be a candidate for radical cystectomy
  • Adequately functioning bladder after thorough evaluation by an urologist
  • No tumor-related hydronephrosis


  • Zubrod performance status 0-1
  • White blood cell count (WBC) ≥ 4,000/mm^3
  • Absolute neutrophil count (ANC) ≥ 1,800/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Serum creatinine ≤ 1.5 mg/dL (serum creatinine ≤ 1.8 mg/dL allowed provided creatinine clearance is > 60 mL/min)
  • Serum bilirubin ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to tolerate systemic chemotherapy combined with pelvic radiotherapy and a radical cystectomy as determined by the urologist, radiation oncologist, and medical oncologist
  • No other malignancy within the past 5 years except for nonmelanoma skin cancer, stage T1a prostate cancer, or carcinoma in situ of the cervix
  • No severe, active co-morbidities, including any of the following:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness that requires hospitalization or precludes study therapy
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS
  • No prior allergic reaction to any of the study drugs


  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior systemic chemotherapy for any cancer
  • No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycosides)
  • No concurrent intensity-modulated radiotherapy

Exclusion criteria

Study Locations And Contact Information

  • St Agnes Hospital Cancer Center, Baltimore Maryland
  • Winship Cancer Institute of Emory University, Atlanta Georgia
  • McGill Cancer Centre at McGill University, Montreal Quebec
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise Idaho
  • West Michigan Cancer Center, Kalamazoo Michigan
  • University of Michigan Comprehensive Cancer Center, Ann Arbor Michigan
  • Saint Joseph Mercy Cancer Center, Ann Arbor Michigan
  • Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta Georgia
  • Hudner Oncology Center at Saint Annes Hospital Fall River, Fall River Massachusetts
  • Cancer Institute at St Johns Hospital, Springfield Illinois
  • Parkview Regional Cancer Center at Parkview Health, Fort Wayne Indiana

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