Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer (NCT00981656) | Clinical Trial Compass
CompletedPhase 2
Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
United States37 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration.
Exclusion criteria
✕. With the presentations as described in Section 2, the participating urologist judges that the standard next therapy, based on present urologic guidelines for this patient, is radical cystectomy.
✕. If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or by percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases will not be eligible.
✕. Patients must have an adequately functioning bladder as judged by the participating urologist and radiation oncologist and have undergone a re-staging TURBT by the participating urologist that showed (or was present in the outside pathology specimen) a high grade stage Ta or T1 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 must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy (if necessary) by the joint agreement of the participating urologist, radiation oncologist, and medical oncologist.
What they're measuring
1
Percentage of Participants Free From Radical Cystectomy at 3 Years
✕. Appropriate stage for protocol entry, based upon the following minimum diagnostic workup within 60 days prior to registration:
✕. Zubrod Performance Status ≤ 1
✕. Age ≥ 18
✕0. Complete blood count (CBC)/differential obtained no more than 30 days prior to registration on study, with adequate bone marrow function defined as follows: