Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Proactive immune tolerance induction
Other interventionProactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Standard Treatment
Other interventionStandard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatin
DrugA chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)
DrugPremedication includes 20 mg of dexamethasone.
Reduced premedication (10 mg)
DrugPremedication includes 20 mg of dexamethasone.
Reduced premedication (5 mg)
DrugPremedication includes 5 mg of dexamethasone.
Treatment groups
1,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedicationExperimental treatment 3 interventions
Group B: (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedicationActive comparator 3 interventions
Group C: (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedicationExperimental treatment 3 interventions
Group D: (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedicationActive comparator 3 interventions
Group E: (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedicationExperimental treatment 3 interventions
Group F: (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedicationActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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 months2
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).3
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 months4
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 patientSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
Seoul National University Boramae Hospital
Collaborator
Korea Health Industry Development Institute
Collaborator
Source ClinicalTrials.gov