Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT05922358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-28
First Post:
2023-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-06-18', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate of 3 cycles of re-chemotherapy with oxaliplatin', 'timeFrame': '2 years', 'description': 'Completion rate of 3 cycles of re-chemotherapy with oxaliplatin'}], 'secondaryOutcomes': [{'measure': "Concordance rate between oxaliplatin skin test results and clinicians' judgment", 'timeFrame': '2 years', 'description': "Concordance rate between oxaliplatin skin test results and clinicians' judgment"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Tumors']}, 'descriptionModule': {'briefSummary': 'The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.', 'detailedDescription': 'The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.\n\nPatients with GI receiving oxaliplatin-containing regimens were prospectively observed, and patients with oxaliplatin grade I-III hypersensitivity reactions judged by clinicians based on clinical symptoms and signs entered the oxaliplatin reuse study . For patients with grade I-III oxaliplatin allergy, oxaliplatin skin test with 3 concentration gradients (0.01 mg/ml, 0.1 mg/ml and 5 mg/ml) was performed, and 5% glucose Water served as a negative control. 15-20 minutes to read test results. If the largest diameter of the rash was greater than 3 mm of the negative control, it was judged as a positive result. Afterwards, interventions were performed in different ways according to the grade of oxaliplatin allergic reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who plan to receive oxaliplatin treatment;\n2. Male or female aged 18-75 year;\n3. ECOG PS 0-2;\n4. The expected survival time is more than 3 months;\n5. Capable and willing to accept survey patients\n\nExclusion Criteria:\n\n1.Patients who were not suitable for the enrollment of this study judged by the investigator'}, 'identificationModule': {'nctId': 'NCT05922358', 'briefTitle': 'Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study', 'orgStudyIdInfo': {'id': 'SYLT-027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypersensitivity group', 'description': 'Corresponding intervention measures are given for different levels of hypersensitivity reactions', 'interventionNames': ['Combination Product: Anti-allergic treatment']}], 'interventions': [{'name': 'Anti-allergic treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'For grade I-III hypersensitivity to oxaliplatin, oxa 0.01 mg/ml, 0.1 mg/ml and 5 mg/ml were used in sequence for skin test. 5% GS was used as a negative control. Test results are read within 15 to 20 minutes.\n\nGrade IV: Permanently stop using oxaliplatin; Grade I-II: Take orally (cetirizine 10 mg bid, dexamethasone 8 mg bid, ranitidine 150 mg bid\\*3dose) the day before the next cycle of oxaliplatin. The infusion rate is 50% of the original rate; if a grade II hypersensitivity reaction occurs again, the treatment method is the same as that of a grade III hypersensitivity reaction.\n\nGrade III: Oral drugs are the same as above. 0.5h before oxaliplatin: dexamethasone 10mg iv, cimetidine 40mg iv, promethazine 25mg im. The first bag of 10% total amount of oxaliplatin + 5% GS500ml: 5ml/h\\*1h, 45ml/h\\*1h, then 225ml/h\\*2 hours; then dexamethasone 10mg iv; the second bag of 90% total Oxa +5%GS500ml: 100ml/h\\*0.5h, then 150ml/h\\*3 hours.', 'armGroupLabels': ['hypersensitivity group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}