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A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin

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Trial Conditions
  • Bladder Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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

Gender: Both
Steward Physician(s)
  • John J. Coen, MD
  • Donald S. Kaufman, MD
  • Cheryl T. Lee, MD
  • Chin-Lee Wu, MD, PhD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • cisplatin
  • fluorouracil
  • gemcitabine hydrochloride
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • John J. Coen, MD
  • Donald S. Kaufman, MD
  • Cheryl T. Lee, MD
  • Chin-Lee Wu, MD, PhD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00777491
Volunteers:  Not Accepting Healthy Volunteers

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