Renal Pelvic and Ureteral Carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient who has diagnosed with urothelial carcinoma of the renal pelvis or ureter supported by histopathology, urine cytology, or fluorescence in situ hybridization (FISH), or confirmed by radiologists and urosurgeons on the basis of CTU or MRU without pathologic or FISH positivity; 2. No distant metastasis was found after comprehensive screening; 3. The patient cannot undergo surgical treatment due to poor general condition, inability to anesthesia, intolerance to surgery, refusal of surgery and other reasons; 4. Aged 18 or above; 5. Expected survival =12 weeks; 6. For female subjects: surgically sterilized, postmenopausal, or have agreed to use at least one medically approved contraceptive method (such as an intrauterine device [IUD], birth control pill, or condom) during study treatment and for a period of 6 months following study treatment; Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects should agree to use at least one medically approved contraceptive method (e.g. condom, abstinence, etc.) during the study period and for 6 months after the study period; 7. Patient who is willing and able to follow trial and follow-up procedures; 8. Patient who is voluntarily agreed to participate in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient who has received abdominal pelvic radiation therapy; 2. Patient who has other serious and uncontrollable comorbidities that may affect protocol compliance or interfere with interpretation of results; 3. Patient who had other malignant tumors within 5 years prior to the start of study administration, except for: Localized low-risk prostate cancer (defined as stage =T2b, gleason score =7, and PSA=20ng/mL at prostate cancer diagnosis (if measured) who had received radical therapy and had no prostate-specific antigen (PSA) recurrence were eligible for this study); Malignancies that can be expected to recover after treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); 4. Patient who is pregnant or lactating women; 5. Patient who is estimated inadequate patient compliance to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse effect;progression free survival;overall survival;quality of life;time of no surgical intervention; | — |
Countries
China
Contacts
Peking University First Hospital