Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
Status: Recruiting
Phase: Phase 2
Diagnosis: Bladder Cancer
NCT ID: NCT00981656
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-040
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.
Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI:
William Shipley, MD,
Massachusetts General Hospital
Site-responsible Investigators:
Clair Beard, MD,
Dana Farber Cancer Institute
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Judith Prisby, 617-632-5068,
jprisby@partners.org
Dana-Farber Cancer Institute:
Meghara Walsh, 617-632-5264,
mwalsh10@partners.org
Dana-Farber Cancer Institute:
Amanda Fredericks, 617-632-5514,
acfredericks@partners.org
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Carcinoma of the bladder pathologically (histologically or cytologically) diagnosed
within the past 10 weeks, meeting either of the following criteria:
- Patients with operable tumors that are primary transitional cell carcinoma of
the bladder exhibiting histologic evidence of invasion into the lamina propria
(disease clinical stage T1) without evidence of muscularis propria invasion
(muscularis propria must be present in the transurethral resection of the
bladder tumor [TURBT] specimen) and are AJCC clinical stage T1, NX or N0, M0
without hydronephrosis
- Patients with disease involvement of the prostatic urethra with transitional
cell carcinoma and have no evidence of stromal invasion of the prostate
- 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
- Must have a T1G2 or T1G3 transitional cell carcinoma that has recurred within 18
months after initial treatment for ≤ T1 tumors (TURBT and intravesical BCG
immunotherapy) or have presented to a participating urologist who judged BCG therapy
is contraindicated because patient may be immunocompromised
- 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
- WBC ≥ 4,000/mm^3
- 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
- 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 patients 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
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 or
radiotherapy fields
- No concurrent drugs that have potential nephrotoxicity or ototoxicity (e.g.,
aminoglycoside)