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

Summary

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.

Conditions

• Bladder Cancer

Interventions

DRUG

induction cisplatin

15 mg/m\^2 administered as a 60-minute infusion on days 1,2,3,8,9,10,15,16,17.

DRUG

induction 5-fluorouracil

400mg/m\^2 administered as a 24-hour infusion on days 1,2,3, and 15,16,17.

DRUG

induction gemcitabine

27 mg/m\^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15, 18, 22, 25.

RADIATION

Induction BID radiation therapy

Twice daily (BID) on days 1-5,8-12,15-17. The first daily treatment consists of 1.6 Gy delivered to the pelvis. The second fraction consists of 1.5 Gy to the bladder for the first 5 treatment days. Then, 1.5 Gy is delivered to bladder tumor volume as the second treatment for the remaining 8 treatment days. The bladder tumor volume receives a total of 40.3 Gy.

RADIATION

Induction QD radiation therapy

Once daily (QD) on days (1-5,8-12,15-19,22-26). For the first 10 treatment days, 2 Gy is delivered to the pelvis. Then, 2 Gy is delivered to the bladder for the next 4 treatment days, followed by 2 Gy to the bladder tumor volume for the remaining 6 treatment days. The bladder tumor volume receives a total of 40 Gy.

RADIATION

Consolidation BID radiation therapy

Twice daily (BID) for 8 days on days 1,2,3,4,5,8,9,10 of consolidation. 1.5 Gy per fraction for a total of 24 Gy delivered to the pelvis.

RADIATION

Consolidation QD radiation therapy

Once daily (QD) pelvic radiation therapy for 12 days on days 1-5,8-12,15-16 of consolidation. 2 Gy per fraction for a total of 24 Gy delivered to the pelvis.

DRUG

consolidation gemcitabine

27 mg/m\^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15 of consolidation.

DRUG

consolidation 5-fluorouracil

400 mg/m\^2 administered as a 24-hour infusion on days 1, 2, 3 and 8, 9, 10 of consolidation.

DRUG

consolidation cisplatin

15 mg/m\^2 administered as a sixty-minute infusion on days 1, 2, 8, 9 of consolidation.

PROCEDURE

radical cystectomy

Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation.

PROCEDURE

Post-Induction Chemoradiotherapy Endoscopic Response Evaluation

Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy.

DRUG

adjuvant gemcitabine

1000 mg/m\^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles.

DRUG

adjuvant cisplatin

70 mg/m\^2 administered as a sixty-minute infusion on day 1 of each 21-day cycle for four cycles.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• John J. Coen, MD · GenesisCare USA

• Philip J. Saylor, MD · Massachusetts General Hospital

• Cheryl T. Lee, MD · University of Michigan Rogel Cancer Center

• Chin-Lee Wu, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2018-02-18

Completion

2022-05-20

Countries

• United States
• Canada

Study Locations