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Clinical Trials in China / NCT06652009
Recruiting Observational

Radical Radiotherapy Versus Radical Surgery for UTUC

NCT06652009 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Observational
Started
2022-01-01
Last updated
2024-10-22

Condition(s) studied

Renal Pelvis Cancer

Investigational drug(s) / intervention(s)

Radical nephroureterectomyRadical radiotherapy

Radical nephroureterectomy: Radical nephroureterectomy

Radical radiotherapy: Radical radiotherapy with stereotactic body radiation therapy (SBRT) or moderately segmented radiotherapy

Study summary

This study is a prospective cohort study, and the proposed plan is to recruit 30 patients with radical radiotherapy for renal pelvic ureteral cancer, according to the actual clinical situation, enrolling the same period of time to choose the operation of the elderly, combined with the risk of anaesthesia or regional lymph node metastasis of the patients, initially tentatively set at 60. The patients were divided into the surgery group and radiotherapy group according to the actual choice of treatment. In the control group, standard nephroureterectomy was used, and in the experimental group, stereotactic body radiation therapy (SBRT) or moderately segmented radical radiotherapy was used.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Uroepithelial carcinoma of the renal pelvis or ureter supported by clinical symptoms, imaging, histopathology, urocytology, or fluorescence in situ hybridisation (FISH), or those who satisfy FISH positivity despite the absence of pathology or the patient's refusal to be punctured and who are judged to have a renal pelvic or ureteral carcinoma by an imaging physician and a urologist on the basis of CTU or MRU or PETCT; No distant metastases were detected on full screening; Patients who are unable to undergo surgical treatment due to poor general condition, inability to be anaesthetised or to tolerate surgery, or refusal to undergo surgery; patients who are over 70 years old; or patients who are less than 70 years old combined with underlying diseases or the presence of regional lymph node metastasis, etc. who are otherwise unable to undergo radical surgery; Expected survival ≥ 6 months; Willingness and ability to comply with trial and follow-up procedural arrangements; voluntarily agree to participate in the study and sign an informed consent form. Exclusion Criteria: * Previous abdominopelvic radiotherapy; Other serious, uncontrolled concomitant disease that may affect adherence to the protocol or interfere with interpretation of results; Other malignancies within 5 years prior to the start of study dosing, with the exception of malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical cancer in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); estimated that patients' adherence to participation in this clinical study was insufficient.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Departmeng of Urology, Peking University First Hospital Beijing China Recruiting
Department of Radiotherapy Oncology, Peking University First Hospital Beijing China Recruiting

More Peking University First Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652009 on ClinicalTrials.gov ↗ ← All trials in China