Bladder cancer
Conditions
Interventions
bladder-preserving group:TURBT+concurrent radio-chemotherapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically (histologically or cytologically) proven diagnosis of primary bladder transitional cell carcinoma with histologic evidence of muscularis propria; 2. Patients must be judged to be medically inappropriate for radical cystectomy. Patients must have undergone as thorough a TURB by a participating urologist as is judged safely possible; 3. Based on the American Joint Committee on Cancer (AJCC), 7th edition: stage of transitional cell carcinoma (TCC) must be stages T2-T4a; Nx, N0 or N1; and M0; 4. Chest x-ray (or chest CT scan) within 8 weeks prior to registration; 5. Abdominal/pelvic CT scan within 8 weeks prior to registration; 6. History and physical examination including vital signs and body surface area within 4 weeks prior to registration; 7. Zubrod performance status of = 2; 8. Aged 18-75 years.
Exclusion criteria
Exclusion criteria: 1. Previous pelvic or abdominal radiation therapy; inflammatory bowel disease; or systemic chemotherapy; 2. Pregnant or nursing women; this exclusion is necessary because treatment involves unforeseeable risks to the participant and to the embryo or fetus. Men or women of childbearing potential who are sexually active and are not willing/able to use; 3. Severe, uncontrollable infective diseases; 4. Symptomatic, uncontrollable hypertension, heart disease, diabetes mellitus, arrhythmia, cerebrovascular disease; Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months; AIDS; Prior allergic reaction to the study drug(s) involved in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of intact-bladder;disease-specific survival; | — |
Countries
China
Contacts
Public ContactGao Xianshu
Peking University First Hospital
Outcome results
None listed