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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00981656 |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy given together with cisplatin works in treating patients with stage I bladder cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Radiation: 3-dimensional conformal radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Cisplatin Chemotherapy Following a Thorough Transurethral Surgical Re-Staging |
| Estimated Enrollment: | 37 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Beginning within 10 weeks of transurethral resection of the bladder tumor, patients undergo 3-dimensional conformal radiotherapy once daily 5 days per week during weeks 1-7 (34 fractions). Patients also receive cisplatin IV on the first 3 days of weeks 1, 3, and 5. Patients with a persistent tumor on re-evaluation may undergo radical cystectomy.
Tissue, blood, and urine samples may be collected periodically for biomarker and other analysis.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Carcinoma of the bladder pathologically (histologically or cytologically) diagnosed within the past 10 weeks, meeting either of the following criteria:
No histologically or cytologically confirmed node metastases
PATIENT CHARACTERISTICS:
No severe, active co-morbidity including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Colorado | |
| Poudre Valley Radiation Oncology | Recruiting |
| Fort Collins, Colorado, United States, 80528 | |
| Contact: Joshua H. Petit 970-482-3328 | |
| United States, Maryland | |
| St. Agnes Hospital Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21229 | |
| Contact: Richard S. Hudes, MD 410-368-2965 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New York | |
| Beth Israel Medical Center - Petrie Division | Recruiting |
| New York, New York, United States, 10003-3803 | |
| Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D 212-844-6286 | |
| St. Luke's - Roosevelt Hospital Center - St.Luke's Division | Recruiting |
| New York, New York, United States, 10025 | |
| Contact: Seth M. Cohen 212-523-4000 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | Recruiting |
| Akron, Ohio, United States, 44309-2090 | |
| Contact: Clinical Trials Office - Akron City Hospital 330-375-6101 | |
| Barberton Citizens Hospital | Recruiting |
| Barberton, Ohio, United States, 44203 | |
| Contact: William F. Demas, MD 330-375-3557 | |
| Cancer Care Center, Incorporated | Recruiting |
| Salem, Ohio, United States, 44460 | |
| Contact: William F. Demas, MD 330-375-3557 | |
| Cancer Treatment Center | Recruiting |
| Wooster, Ohio, United States, 44691 | |
| Contact: Clinical Trials Office - Cancer Treatment Center 330-375-4221 | |
| Study Chair: | William U. Shipley, MD, FACR | Massachusetts General Hospital |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00981656 History of Changes |
| Other Study ID Numbers: | CDR0000654727, RTOG-0926 |
| Study First Received: | September 19, 2009 |
| Last Updated: | January 19, 2012 |
| Health Authority: | Unspecified |
|
stage I bladder cancer transitional cell carcinoma of the bladder |
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |