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

Study acronym: iNDUCT
StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since May 2023); last known: Recruiting
  2. Enrollment target: 99 to 50 Primary completion date: Jan 1, 2024 to Jan 1, 2025 · Study sites: 8 to 9 · Completion date: Oct 1, 2025 to Oct 1, 2026 · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Jan 1, 2024 to Jan 1, 2025
    • Study sites: 8 to 9
    • Completion date: Oct 1, 2025 to Oct 1, 2026
    • Eligibility criteria expanded, about 33 words
    • Collaborators revised (9)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 1 to 8 Collaborators revised (9)v3 Show 1 more changeShow less
    • Collaborators revised (9)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jun 1, 2020 to Sep 29, 2021 Completion date: Jun 1, 2024 to Oct 1, 2025 · Collaborators revised (9) · Eligibility criteria expanded, about 3 wordsv2 Show 3 more changesShow less
    • Completion date: Jun 1, 2024 to Oct 1, 2025
    • Collaborators revised (9)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov