No phaseRecruiting
Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer
- Sponsor
- Seoul National University Hospital (Academic or other)
- Enrolment
- 1,000 planned
- Conditions
- Ovarian Cancer; Endometrial Cancer; Cervical Cancer
- Interventions
- Proactive immune tolerance induction; Standard Treatment; Paclitaxel and carboplatin; Standard premedication (20 mg); Reduced premedication (10 mg); Reduced premedication (5 mg)
- Ages
- adults, older adults
- Registry
- NCT06977594
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Hypersensitivity reaction incidence
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered