Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy |
| Estimated Enrollment: | 84 |
| Study Start Date: | September 1999 |
OBJECTIVES:
- Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder previously treated with transurethral tumor resection.
- Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy in achieving a complete response in this patient population.
- Assess the value of tumor parameters as prognostic factors for initial tumor response and recurrence-free survival in this patient population.
OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17.
Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after evaluation, patients with complete response receive consolidation therapy comprising paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9, and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo a cystectomy.
At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of the bladder with muscle invasion
- Resectable disease
- Prostatic urethral involvement with transitional cell carcinoma allowed, if completely resected and no evidence of stromal invasion
- No tumor-related hydronephrosis
Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle biopsy
- No nodal metastases
- No distant metastases
No more than 6 weeks since prior transurethral resection of the bladder tumor
- Functioning bladder
PATIENT CHARACTERISTICS:
Age:
- Adult
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 4,000/mm^3
- Absolute neutrophil count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
Other:
- No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the cervix
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Medically operable
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 potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)
Contacts and Locations
Show 229 Study Locations| Study Chair: | Donald S. Kaufman, MD | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003930 History of Changes |
| Other Study ID Numbers: | CDR0000067122, RTOG-9906, RTOG-DEV-14321 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 1, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II bladder cancer stage III bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013