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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Standard treatment throughout all chemotherapy cycles
A chemotherapy regimen for gynecologic cancers.
Premedication includes 20 mg of dexamethasone.
Premedication includes 20 mg of dexamethasone.
Premedication includes 5 mg of dexamethasone.
Seoul National University Hospital
Seoul, South Korea
Hypersensitivity reaction incidence
Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / total chemotherapy administrations) × 100. Hypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria.
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).
Chemotherapy completion rate
Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.
Time frame: From chemotherapy initiation to the last cycle in each patient, an average of 6 months
Severity of hypersensitivity reaction
Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).
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
Patients' quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better outcomes for the Global Health Status and Functional Scales, whereas higher scores on the Symptom Scales indicate worse symptoms.
Time frame: From chemotherapy initiation to the last cycle, an average of 6 months
Tumor Response Rate
Tumor response rate is defined as the proportion of patients who experience tumor size reduction or disappearance in response to chemotherapy. It is calculated as the proportion of patients who achieve a complete response (disappearance of all tumors with no evidence of new lesions) or a partial response (at least a 30% reduction in the size of tumors, with no appearance of new lesion) after planned chemotherapy.
Time frame: At every third chemotherapy cycle in each patient
Survival rate
Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy.
Time frame: At study completion in each patient, an average of 1 year
Recurrence Rate
Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment.
Time frame: At study completion in each patient, an average of 1 year
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