Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
stage I bladder cancer, transitional cell carcinoma of the bladder
Study Type
Interventional
Study Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin Type: Drug
Name: fluorouracil Type: Drug
Name: mitomycin C Type: Drug
Overall Status
Recruiting
Summary
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, mitomycin C, and fluorouracil, 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 chemotherapy works in treating patients with stage I bladder cancer.
Detailed Description
OBJECTIVES:

Primary

- To evaluate the rate of freedom from radical cystectomy at 3 years.

Secondary

- To evaluate the rate of freedom from radical cystectomy at 5 years.

- To evaluate the rate of freedom from the development of distant disease progression at 3 and 5 years.

- To evaluate the rate of freedom from progression of bladder tumor to stage T2 or greater at 3 and 5 years.

- To evaluate disease-specific survival and overall survival.

- To evaluate the incidence of acute and late pelvic toxicity.

- To evaluate the efficacy of this treatment approach in preventing the recurrence of any local bladder tumor.

- To evaluate the potential value of tumor histopathology plus molecular genetic, DNA content, and urine proteomics parameters as possible significant prognostic factors for tumor control with this treatment approach.

- To collect American Urological Association symptom scores at baseline and at 3 years.

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 1 of 2 radiosensitizing chemotherapy regimens concurrently with radiotherapy.

- Regimen I: Patients receive cisplatin IV on days 1-3 of weeks 1, 3, and 5.

- Regimen II: Patients receive mitomycin C IV on day 1 of radiotherapy and fluorouracil IV continuously over days 1-5 of weeks 1 and 4.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Pathologically (histologically or cytologically) diagnosis of carcinoma of the bladder within 105 days prior to registration.

- Patients with operable tumors that are primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis.

- Patients with disease involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate. If the patient's initial tumor was a high grade Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible.

- Patients must have a high grade urothelial carcinoma stage Ta or T1 that has recurred within 540 days after completion of the initial treatment (transurethral resection bladder tumor [TURBT] and intravesical bacillus Calmette-Guerin [BCG] immunotherapy) or have presented to a participating urologist who judged BCG therapy is contraindicated because this patient may be immuno-compromised or because the patients refuses BCG therapy

- No confirmed tumor-related hydronephrosis

- No pN+ or > T1 disease

- No histologically or cytologically confirmed node metastases

- If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy

- No evidence of distant metastases

- Patients for whom radical cystectomy is the standard next therapy per urologic guidelines, in the judgement of the participating urologist, are eligible

- Must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a visibly complete re-staging TURBT by the participating urologist that shows (or is present on the outside pathology specimen) a T1G2 or T1G3 tumor with uninvolved muscularis propria in the specimen and, if on prostatic urethral biopsy mucosal carcinoma is present, there is no evidence on biopsy in the prostatic stroma of tumor invasion

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- White blood cell count (WBC) ≥ 4,000/mm^3

- Absolute neutrophil count (ANC) ≥ 1,800/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- Serum creatinine ≤ 1.5 mg/dL

- Serum bilirubin ≤ 2.0 mg/dL

- Glomerular filtration rate (GFR) > 25 mL/min (for patients receiving cisplatin, GFR > 60 mL/min)

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate systemic chemotherapy combined with radiotherapy and a radical cystectomy (if necessary), in the opinions of the urologist, radiation oncologist, and medical oncologist

- No prior or concurrent malignancy of any other site or histology (except for nonmelanomatous skin cancer, T1a prostate cancer, or carcinoma in situ of the uterine cervix) unless the patient has been disease-free for ≥ 5 years

- No severe, active co-morbidity including any of the following:

- Unstable angina and/or congestive heart failure that required hospitalization within the past 6 months

- Transmural myocardial infarction that occurred within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics at the time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding any study therapy at the time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS based upon the current Centers for Disease Control definition (HIV testing not required)

- No prior allergic reaction to cisplatin, mitomycin, or 5-fluorouracil

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for bladder cancer

- Prior chemotherapy for a different cancer allowed

- No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields

- No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g., aminoglycoside)
Locations
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Peter J. Rossi - 404-686-4411
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Clinical Trials Office - Winship Cancer Institute - 404-778-1900
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Richard S. Hudes, MD - 410-368-2965
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
Status: Recruiting
Contact: Clinical Trials Office - Hudner Oncology Center at Saint Anne' - 508-674-5600
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Clinical Trials Office - Norris Cotton Cancer Center - 603-650-7609 - cancerhelp@dartmouth.edu
Beth Israel Medical Center - Petrie Division
New York, New York, United States
Status: Recruiting
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D - 212-844-6286
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Status: Recruiting
Contact: Clinical Trials Office - Akron City Hospital - 330-375-6101
Barberton Citizens Hospital
Barberton, Ohio, United States
Status: Recruiting
Contact: William F. Demas, MD - 330-375-3557
Cancer Care Center, Incorporated
Salem, Ohio, United States
Status: Recruiting
Contact: William F. Demas, MD - 330-375-3557
Cancer Treatment Center
Wooster, Ohio, United States
Status: Recruiting
Contact: Clinical Trials Office - Cancer Treatment Center - 330-375-4221
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi - 215-728-4790
University of Texas Medical Branch
Galveston, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Texas Medical Branch - 409-772-1950
Norris Cotton Cancer Center - North
Saint Johnsbury, Vermont, United States
Status: Recruiting
Contact: Alan C. Hartford, MD, PhD - 603-650-6600
Start Date
November 2009
Sponsors
Radiation Therapy Oncology Group
Source
Radiation Therapy Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page