Clinical trial NCT06120374: Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
Official title: Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Keywords: upper tract urothelial carcinoma
adjuvant therapy
adjuvant radiotherapy
adjuvant chemotherapy
immunotherapy
safety analysis
progression free survival
overall survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk UTUC patients (met at least one of indications such as: 1. pT2+, 2.G3/High-grade, 3.Multifocality, 4. Positive surgical margin, 5. Positive lymph-node metastasis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: 1-year, 3-year and 5-year
Secondary outcomes:
measure: OS
timeFrame: 1-year, 3-year and 5-year
measure: CSS
timeFrame: 1-year, 3-year and 5-year
measure: LRFS
timeFrame: 1-year, 3-year and 5-year
measure: MFS
timeFrame: 1-year, 3-year and 5-year
measure: IRFS and CRFS
timeFrame: 1-year, 3-year and 5-year
Other outcomes:
measure: AE
timeFrame: Peri-therapeutic period
Locations:
city: Beijing
country: China
facility: Departmeng of Urology, Peking University First Hospital
city: Beijing
country: China
facility: Department of Medical Oncology, Peking University First Hospital
city: Beijing
country: China
facility: Department of Radiotherapy Oncology, Peking University First Hospital
Study officials:
affiliation: Department of Radiotherapy Oncology, Peking University First Hospital
name: Xiaoying Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, Peking University First Hospital
name: Liqun Zhou, M.D.
role: STUDY_CHAIR
References:
citation: Seisen T, Krasnow RE, Bellmunt J, Roupret M, Leow JJ, Lipsitz SR, Vetterlein MW, Preston MA, Hanna N, Kibel AS, Sun M, Choueiri TK, Trinh QD, Chang SL. Effectiveness of Adjuvant Chemotherapy After Radical Nephroureterectomy for Locally Advanced and/or Positive Regional Lymph Node Upper Tract Urothelial Carcinoma. J Clin Oncol. 2017 Mar 10;35(8):852-860. doi: 10.1200/JCO.2016.69.4141. Epub 2017 Jan 3.
citation: Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.
citation: Li X, Li H, Gao XS, Fang D, Qin S, Zhang Z, Zhou L, Li X, Wang D. Effectiveness of adjuvant radiotherapy for high recurrence risk patients with upper tract urothelial carcinoma. Urol Oncol. 2022 Sep;40(9):410.e1-410.e10. doi: 10.1016/j.urolonc.2022.03.006. Epub 2022 Apr 14.
citation: Li X, Cui M, Gu X, Fang D, Li H, Qin S, Yang K, Zhu T, Li X, Zhou L, Gao XS, Wang D. Pattern and risk factors of local recurrence after nephroureterectomy for upper tract urothelial carcinoma. World J Surg Oncol. 2020 May 30;18(1):114. doi: 10.1186/s12957-020-01877-w.