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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Korea Health Industry Development Institute | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication | Experimental | 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. |
|
| (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active Comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
|
| (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication | Experimental | 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. |
|
| (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active Comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive immune tolerance induction | Other | Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From chemotherapy initiation to the last cycle in each patient, an average of 6 months |
| Severity of hypersensitivity reaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye-Ryun Kang, MD, PhD | Contact | +82-2-2072-0820 | helenmed@snu.ac.kr | |
| Jiyeon Park, MD | Contact | +82-2-2072-3291 | creativepennant@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
IPD will not be shared due to institutional policies regarding data confidentiality.
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A randomized, placebo-controlled, parallel-group, open-label, clinical trial
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| (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication | Experimental | 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. |
|
| (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active Comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
|
| Standard Treatment | Other | Standard treatment throughout all chemotherapy cycles |
|
| Paclitaxel and carboplatin | Drug | A chemotherapy regimen for gynecologic cancers. |
|
| Standard premedication (20 mg) | Drug | Premedication includes 20 mg of dexamethasone. |
|
| Reduced premedication (10 mg) | Drug | Premedication includes 20 mg of dexamethasone. |
|
| Reduced premedication (5 mg) | Drug | Premedication includes 5 mg of dexamethasone. |
|
Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE). |
| 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. | 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. | 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. | 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. | At study completion in each patient, an average of 1 year |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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