Clinical Trial

Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract

Study acronym: iNDUCT

Recruiting Phase 2

Record status

This record was last updated May 30, 2023 (before its estimated January 1, 2025 completion). Its status may not reflect the trial's current state.

Summary

Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively. The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2020-11-03; most recent amendment 2023-05-26.

Trial Details

NCT Number	NCT04617756
Lead Sponsor	Centre Hospitalier Universitaire de Nīmes Collaborators: Pitié-Salpêtrière Hospital, Bichat Hospital, Hopital Foch 92151 Suresnes, Institut Paoli-Calmettes, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France, Centre Hospitalier Lyon Sud, Center Eugene Marquis, IUCT ONCOPOLE
Conditions	Urothelial Carcinoma, Cancer
Enrollment	50 participants
Start Date	2021-09-29
Primary Completion	2025-01-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2023-05-30