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Sponsored by: |
Institute of Cancer Research, United Kingdom |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00867347 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective than surgery in treating patients with bladder cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with surgery in treating patients with bladder cancer who are receiving chemotherapy.
Condition | Intervention | Phase |
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Bladder Cancer |
Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study |
Estimated Enrollment: | 1015 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy. |
Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
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Arm II: Experimental
Patients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
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Radiation: radiation therapy
Patients undergo radiotherapy
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2, macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment according to randomization arm.
NOTE: *Patients with a clear bladder or those who are unsure of their histological results prior to course 4 also proceed to chemotherapy.
Health-related quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the bladder
No adenocarcinoma, squamous cell carcinoma (SCC), small cell carcinoma, or other variant histology
No simultaneous upper tract, urethral, or prostatic urethral TCC
PATIENT CHARACTERISTICS:
No untreated hydronephrosis
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Institute of Cancer Research - Sutton | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Robert A. Huddart, MD 44-20-8661-3457 spare-icrctsu@icr.ac.uk |
Principal Investigator: | Robert A. Huddart, MD | Royal Marsden - Surrey |
Study ID Numbers: | CDR0000633526, ICR-SPARE, ISRCTN61126465, EU-20907, ICR-CTSU/2006/10002 |
Study First Received: | March 20, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00867347 History of Changes |
Health Authority: | Unspecified |
transitional cell carcinoma of the bladder stage II bladder cancer stage III bladder cancer |
Urinary Tract Neoplasm Cystocele Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Bladder Neoplasm Urologic Neoplasms Carcinoma, Transitional Cell Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Carcinoma |