Urothelial Carcinoma
Conditions
Keywords
upper tract urothelial carcinoma, adjuvant therapy, adjuvant radiotherapy, adjuvant chemotherapy, immunotherapy, safety analysis, progression free survival, overall survival
Brief summary
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.
Detailed description
This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.
Interventions
RADIATIONRadiotherapy
For participants eligible for enrollment, radiotherapy was started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT) with daily image-guided radiotherapy (Daily IGRT) technique was used. Range of irradiation (patients were randomized into two groups - expanded field irradiation group and involved field irradiation group)
DRUGChemotherapy
For patients eligible for enrollment, postoperative adjuvant chemotherapy was initiated at about 4-6 weeks after surgery, for a total of 4 cycles, with the chemotherapy regimen of gemcitabine + cisplatin. Administration: Gemcitabine 1,000 mg/m2 on days 1 and 8 (completed within 30-60 minutes), cisplatin 70 mg/m2 on day 1.
DRUGImmunotherapy
For patients eligible for enrollment, sequential adjuvant immuotherapy was initiated at about 4-6 weeks after surgery, Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC); * High-risk UTUC: \>= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition); * Aged \>= 18 years old;
Exclusion criteria
* With Distant metastases already found at the time of surgery; non-R0 resected ; * History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; * Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception; * 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); * Weight loss \> 10% within 6 months; * Existing or coexisting bleeding disorders, active infection; * Terrible condition cannot tolerate the intervention; * Unable to sign informed consent due to psychological, family, social and other factors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1-year, 3-year and 5-year | Progression-free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 1-year, 3-year and 5-year | Overall survival |
| CSS | 1-year, 3-year and 5-year | Cancer specific survival |
| MFS | 1-year, 3-year and 5-year | Metastasis free survival |
| IRFS and CRFS | 1-year, 3-year and 5-year | intravesical-recurrence free survival and contralateral-recurrence free survival |
| LRFS | 1-year, 3-year and 5-year | Local recurrence free survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| AE | Peri-therapeutic period | Adverse effects |
Countries
China
Contacts
Primary ContactXuesong Li, M.D.
Backup ContactChunru Xu, M.D.
Outcome results
None listed