Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proactive immune tolerance induction, Standard Treatment, Paclitaxel and carboplatin, Standard premedication (20 mg).
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Endometrial Cancer, Cervical Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.
Interventions
- Other Proactive immune tolerance induction
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles - Other Standard Treatment
Standard treatment throughout all chemotherapy cycles - Drug Paclitaxel and carboplatin
A chemotherapy regimen for gynecologic cancers. - Drug Standard premedication (20 mg)
Premedication includes 20 mg of dexamethasone. - Drug Reduced premedication (10 mg)
Premedication includes 20 mg of dexamethasone. - Drug Reduced premedication (5 mg)
Premedication includes 5 mg of dexamethasone.
Primary outcome measures
- Hypersensitivity reaction incidence [Time frame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).]
Secondary outcome measures (6)
- Chemotherapy completion rate [Time frame: From chemotherapy initiation to the last cycle in each patient, an average of 6 months]
- Severity of hypersensitivity reaction [Time frame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).]
- Patients' quality of life [Time frame: From chemotherapy initiation to the last cycle, an average of 6 months]
- Tumor Response Rate [Time frame: At every third chemotherapy cycle in each patient]
- Survival rate [Time frame: At study completion in each patient, an average of 1 year]
- Recurrence Rate [Time frame: At study completion in each patient, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies.
- 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 do not wish to participate in this study voluntarily.
- Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06977594 · PINTO_C