This study is NOT currently recruiting participants.
Number
13-C-0175
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Cystoscopic Surveillance; Bladder Cancer; Radiation Therapy; Bladder Conservation; Chemotherapy
Recruitment Keyword(s)
None
Condition(s)
Bladder Cancer; Bladder Neoplasms; Bladder Tumors; Urothelial Cancer; Urinary Bladder Cancer
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Cisplatin Drug: Mitomycin Drug: 5FU Radiation: Radiation Therapy
Supporting Site
National Cancer InstituteMassachusetts General HospitalRadiation Therapy Oncology Group
- People with a certain type of Stage T1 bladder cancer that has not responded to standard treatment usually must have their bladder removed. But recent reports in more advanced bladder cancer suggest a more limited surgery, then radiation therapy plus chemotherapy, can destroy this cancer. Most who received this treatment did not need their bladder removed, and kept good bladder function. This approach is experimental for this cancer; researchers do not know its effects or how well it works.
Objectives:
- To learn the effects of transurethral surgery then radiation therapy plus chemotherapy on people with Stage T1 bladder cancer.
Eligibility:
- Adults 18 years and older, with bladder cancer that has not responded to standard treatment.
Design:
- Participants will be screened with a medical history and physical exam. Before the study, their bladder tumor will be surgically removed through the urethra.
- Participants will have blood tests, bone tests, a bladder exam, and body scans all part of regular cancer treatment.
- Participants will receive radiation treatment once a day, 5 days a week, for about 7 weeks.
- Some will receive chemotherapy drug cisplatin through a tube in their vein, 3 days a week, for three of the radiation weeks.
- Others will receive chemotherapy drug mitomycin in their vein on 1 day. Then they will continuously receive drug 5FU through a pump attached to a tube in their vein, during weeks 1 and 4. They do not have to stay at the clinic for this.
- Within 10 weeks later, participants will answer questions and have a bladder exam, urine tests, and a small piece of the bladder removed and tested. Similar follow-up visits will continue for several years.
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INCLUSION & EXCLUSION CRITERIA: -Operable patients with Stage T1 disease (T1G2 or T1G3) for whom radical cystectomy is being considered as the next conventional step in therapy by standard urologic guidelines -AJCC Stages T1, NX or N0, M0, only transitional cell histology -Restaged by a urologist in the participating institution with an aggressive, visibly complete TURBT with muscularis propria in the specimen but with no evidence of its invasion by tumor -Failed standard treatment with, or is medically ineligible for, intravesical biological therapy or chemotherapy -No evidence of prostatic stromal invasion by tumor
-Operable patients with Stage T1 disease (T1G2 or T1G3) for whom radical cystectomy is being considered as the next conventional step in therapy by standard urologic guidelines
-AJCC Stages T1, NX or N0, M0, only transitional cell histology
-Restaged by a urologist in the participating institution with an aggressive, visibly complete TURBT with muscularis propria in the specimen but with no evidence of its invasion by tumor
-Failed standard treatment with, or is medically ineligible for, intravesical biological therapy or chemotherapy
-No evidence of prostatic stromal invasion by tumor
Principal Investigator
Referral Contact
For more information: