Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for UTUC

Sponsor

Peking University First Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06120374

Collaborator

(none)

300

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is an ambispective cohort observational study to analyze the efficacy of surgery alone versus postoperative adjuvant therapy (postoperative radiotherapy/postoperative chemotherapy(immunotherapy)/ combined strategy) 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.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma	Radiation: Radiotherapy Drug: Chemotherapy and immunotherapy Combination Product: Combined adjuvant therapy

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Safety and Efficacy of Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Oct 30, 2026

Anticipated Study Completion Date :

Oct 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Surveillance alone Participants underwent radical total nephroureterectomy alone (with or without lymph node dissection) without postoperative adjuvant therapy
Adjuvant chemotherapy/immunotherapy Participants underwent radical total nephroureterectomy and adjuvant chemotherapy/immunotherapy postoperatively.	Drug: Chemotherapy and immunotherapy 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. Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.
Adjuvant radiotherapy Participants underwent radical total nephroureterectomy and adjuvant radiotherapy postoperatively.	Radiation: Radiotherapy 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)
Adjuvant combined therapy Participants underwent radical total nephroureterectomy (with or without lymph node dissection) with a combination of adjuvant chemotherapy/immunotherapy and radiation therapy postoperatively	Combination Product: Combined adjuvant therapy For patients eligible for enrollment, sequential adjuvant radiotherapy (same as the radiotherapy group) and systemic drug therapy (same as the chemotherapy group; immunotherapy drugs can be PD-1 or PDL-1) can be started at about 4-6 weeks after surgery. The specific dose of drugs can be adjusted according to the actual tolerability of the patient, such as reducing or replacing the regimen, or interrupting the regimen.

Outcome Measures

Primary Outcome Measures

PFS [1-year, 3-year and 5-year]
Progression-free Survival

Secondary Outcome Measures

OS [1-year, 3-year and 5-year]
Overall survival
CSS [1-year, 3-year and 5-year]
Cancer specific survival
LRFS [1-year, 3-year and 5-year]
Local recurrence free 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

Other Outcome Measures

AE [Peri-therapeutic period]
Adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >= 18 years old;

Exclusion Criteria:

1. Distant metastases already found at the time of surgery; non-R0 resected patients;

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;
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.

Contacts and Locations

Locations

	Site	City	Country
1	Departmeng of Urology, Peking University First Hospital	Beijing	China
2	Department of Medical Oncology, Peking University First Hospital	Beijing	China
3	Department of Radiotherapy Oncology, Peking University First Hospital	Beijing	China

Sponsors and Collaborators

Peking University First Hospital

Investigators

Principal Investigator: Xiaoying Li, M.D., Department of Radiotherapy Oncology, Peking University First Hospital
Study Chair: Liqun Zhou, M.D., Department of Urology, Peking University First Hospital