Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
NCT ID: NCT06977594
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-06-25
2028-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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(Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication
Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone.
Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
(Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication
Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
Standard Treatment
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
(Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication
Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone.
Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Reduced premedication (10 mg)
Premedication includes 20 mg of dexamethasone.
(Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication
Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
Standard Treatment
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
(Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication
Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone.
Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Reduced premedication (5 mg)
Premedication includes 5 mg of dexamethasone.
(Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication
Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone.
Standard Treatment
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
Interventions
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Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Standard Treatment
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone.
Reduced premedication (10 mg)
Premedication includes 20 mg of dexamethasone.
Reduced premedication (5 mg)
Premedication includes 5 mg of dexamethasone.
Eligibility Criteria
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Inclusion Criteria
* Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin.
* Patients who are able to read and voluntarily provide written informed consent.
* Aged 19 years or older.
Exclusion Criteria
* Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
19 Years
FEMALE
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Boramae Hospital
OTHER
Korea Health Industry Development Institute
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Hye-Ryun Kang
Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PINTO_C
Identifier Type: -
Identifier Source: org_study_id
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