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NOT YET RECRUITING
NCT06472752

Neoadjuvant Radiotherapy for High-risk UTUC

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

The investigators propose to conduct an open-label, single-arm, prospective cohort study to collect and observe high-risk UTUC patients (with clear pathology of urothelial carcinoma and at least one of the following (muscle invasion \[cT2 and above\], high-grade tumour, multifocality, tumour diameter of ≥2cm, with hydronephrosis or regional lymph node metastasis) who undergo neoadjuvant therapy(neoadjuvant radiotherapy with/without drug) + radical nephroureterectomy. The cohort was evaluated by regular follow-up for safety and prognosis during the real-world neoadjuvant treatment period, perioperative period, and long-term postoperative follow-up.

Official title: Efficacy and Safety of Neoadjuvant Radiotherapy for High-risk Upper Tract Urothelial Carcinoma: A Single-arm, Open Label, Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2024-06-30

Completion Date

2029-06-30

Last Updated

2024-06-25

Healthy Volunteers

No

Interventions

RADIATION

Neoadjuvant radiotherapy

Patients with a clear pathological diagnosis of high-risk UTUC were treated with a short course of 5 days of naSBRT: radiotherapy irradiation was directed to the primary lesion on the affected side and to the lymphatic drainage area, with a dose of 25 Gy (5 Gy\*5 days).The safety of the neoadjuvant radiotherapy dose and regimen can be evaluated by metrological ramping in the initial 5 patients, with subsequent patients following the optimal dose from ramping.

COMBINATION_PRODUCT

Neoadjuvant drug therapy

Patients will concurrently complete at least 2-4 cycles of preoperative neoadjuvant chemotherapy/immunotherapy/ADCs as well.

Locations (1)

Departmeng of Urology, Peking University First Hospital

Beijing, China