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Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jun 25, 2025 to May 21, 2025 · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 2 of 6 entries · 1 more Show 4 more changesShow less
    • Start date changed from estimate of Jun 25, 2025 to May 21, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised
  2. Start date: Jun 1, 2025 to Jun 25, 2025v3
  3. Enrollment target: 1028 to 1000 Interventions: Paclitaxel and carboplatin (Drug), Proactive immune tolerance induction (Other), Standard Treatment (Other) to Paclitaxel and carboplatin (Drug), Proactive immune tolerance induction (Other), Reduced premedication (10 mg) (Drug), Reduced… · Secondary endpoints: 3 to 6 · Study description expanded, about 7 words · 2 morev2 Show 5 more changesShow less
    • Interventions: Paclitaxel and carboplatin (Drug), Proactive immune tolerance induction (Other), Standard Treatment (Other) to Paclitaxel and carboplatin (Drug), Proactive immune tolerance induction (Other), Reduced premedication (10 mg) (Drug), Reduced…
    • Secondary endpoints: 3 to 6
    • Study description expanded, about 7 words
    • Study arms: 2 to 6
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. The main questions it aims to answer are: \- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles? Participants will: * Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment. * Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.
Trial Details
NCT Number NCT06977594
Lead Sponsor Seoul National University Hospital
Collaborators: Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Korea Health Industry Development Institute
Conditions Ovarian Cancer, Endometrial Cancer, Cervical Cancer
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov