Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer

• Status: Completed
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI); NRG Oncology
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Gemcitabine; Paclitaxel

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)