upper tract urothelial carcinoma
Conditions
Interventions
Simple surgery:Radical total nephroureterectomy alone (with or without lymph node dissection) without postoperative adjuvant therapy
surgery and adjuvant radiotherapy:Radical total nephroureterectomy (with or without lymph node dissection) with postoperative adjuvant radiotherapy
surgery and adjuvant chemotherapy:Radical total nephroureterectomy (with or without lymph node dissection) with postoperative adjuvant chemotherapy
Sponsors
Department of Urology, Peking University First Hospital, Peking University Institute of Urology, National Urological Male Genital Tumor Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC), without any serious complication; 2. Meet any of the following conditions: >= pT2,pN+,tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition); 3. Aged from 18 to 80 years; 4. Abdominopelvic CT completed 4 weeks prior to enrollment; 5. Patients were free of other malignant diseases within the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; 6. Willing to participate in this trial and sign the informed consent. 7. Expected survival >6 months; 8. KPS >70 points; 9. leukocytes >=3.5x10^9/l, neutrophils >=1.5x10^9/l, platelets >=100.0x10^9/l, hemoglobin >=90g/l.
Exclusion criteria
Exclusion criteria: 1. Distant metastases already found at the time of surgery; non-R0 resected patients; 2. History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3. Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; 4. History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years); 5. Weight loss > 10% within 6 months; 6. Existing or coexisting bleeding disorders, active infection; 7. Clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, New York Heart Association (NYHA) >= Class II congestive heart failure, unstable symptomatic arrhythmia, or >=Class II peripheral vascular disease); 8. Those who are unable to sign informed consent due to psychological, family, social and other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Cancer specific survival;Distant-metastasis free survival;Locoregional recurrence free survival;Incidence of bladder tumors and contralateral tumors; | — |
Countries
China
Contacts
Public ContactLiqun Zhou
Department of Urology, Peking University First Hospital, Peking University Institute of Urology, National Urological Male Genital Tumor Research Center
Outcome results
None listed