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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00777491 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy |
| Estimated Enrollment: | 98 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive induction therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 8-10.
|
Drug: cisplatin
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Given once or twice daily
|
|
Experimental: Arm II
Patients receive induction therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 8-10.
|
Drug: gemcitabine hydrochloride
Given IV
Radiation: radiation therapy
Given once or twice daily
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 6 weeks
Clinical stage T2-T4a, NX or N0, M0 disease
No histologically or cytologically confirmed lymph node metastases
Operable disease
PATIENT CHARACTERISTICS:
No severe, active co-morbidities, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Georgia | |
| Georgia Cancer Center for Excellence at Grady Memorial Hospital | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Ashesh B. Jani 773-702-2526 | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Clinical Trials Office - Winship Cancer Institute 404-778-1900 | |
| United States, Indiana | |
| Parkview Regional Cancer Center at Parkview Health | Recruiting |
| Fort Wayne, Indiana, United States, 46805 | |
| Contact: Brian K. Chang 260-373-7850 | |
| United States, Maryland | |
| St. Agnes Hospital Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21229 | |
| Contact: Richard S. Hudes, MD 410-368-2965 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | Recruiting |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Contact: Luis Souhami 514-398-1444 | |
| Study Chair: | John J. Coen, MD | Massachusetts General Hospital |
| Investigator: | Donald S. Kaufman, MD | Massachusetts General Hospital |
| Investigator: | Cheryl T. Lee, MD | University of Michigan Cancer Center |
| Study Chair: | Chin-Lee Wu, MD, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00777491 History of Changes |
| Other Study ID Numbers: | CDR0000616858, RTOG-0712 |
| Study First Received: | October 21, 2008 |
| Last Updated: | February 9, 2012 |
| Health Authority: | Unspecified |
|
stage II bladder cancer stage III bladder cancer transitional cell carcinoma of the bladder |
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |