Bladder Cancer Clinical Trial
Official title:
A Phase II Randomized Trial for Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery and BID Irradiation Plus Either Paclitaxel and Cisplatin or 5-Fluorouracil and Cisplatin Followed by Selective Bladder Preservation and Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy
Verified date | May 2018 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Radiation therapy (RT) uses high-energy x-rays to
damage tumor cells. It is not yet known which regimen of combination chemotherapy plus
radiation therapy with or without surgery is more effective in treating bladder cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of two combination chemotherapy
regimens and radiation therapy with or without radical cystectomy in treating patients who
have stage II or stage III bladder cancer.
Status | Completed |
Enrollment | 97 |
Est. completion date | May 14, 2018 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed operable primary muscle invasive bladder cancer - T2-T4a, NX or N0, M0 (stage II or III) - Must have an adequate functioning bladder - Must have undergone a prior transurethral resection of the bladder tumor within the past 8 weeks - No evidence of tumor-related hydronephrosis - No evidence of distant metastases or histologically or cytologically confirmed lymph node metastases - Patients with involvement of the prostatic urethra with transitional cell cancer that was visibly completely resected are allowed - No evidence of stromal invasion of the prostate PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin at least 10 g/dL - White blood cell (WBC) count at least 4,000/mm^3 - Absolute neutrophil count at least 1,800/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Serum bilirubin no greater than 2.0 mg/dL Renal - Serum creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 60 mL/min NOTE: If the creatinine clearance is greater than 60 mL/min, creatinine of no greater than 1.8 mg/dL is allowed at the discretion of the study chair Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except nonmelanoma skin cancer, stage T1a prostate cancer, or carcinoma in situ of the cervix - Must be able to tolerate systemic chemotherapy with pelvic radiotherapy and radical cystectomy 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 drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycosides) |
Country | Name | City | State |
---|---|---|---|
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | Eastern Cooperative Oncology Group, National Cancer Institute (NCI), NRG Oncology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Completion Rate | Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction. | From randomization to 11 weeks | |
Secondary | Complete Response After Induction | Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass. | From randomization to eight weeks | |
Secondary | Bladder-intact Survival Rate (5 Years) | Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method. | From the date of randomization to five years. |
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