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Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for UTUC

Adjuvant Radiotherapy and Combined Adjuvant Treatment Strategy for UTUC

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

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; 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.

Study details
    Urothelial Carcinoma

NCT06120374

Peking University First Hospital

27 January 2024

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