Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04224402
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2019-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'adverse events and severe adverse events', 'timeFrame': 'Up to 12 weeks', 'description': 'number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0'}, {'measure': 'EORTC Quality of Life Questionnaire(QLQ)-C30', 'timeFrame': 'Up to 24 weeks', 'description': 'Quality of life will be assessed at each study using EORTC QLQ-C30'}], 'primaryOutcomes': [{'measure': 'Regression Free Survival', 'timeFrame': 'Up to 24 months', 'description': 'defined as the period from the date of resection to tumor relapse caused by any reason'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 24 months', 'description': "the duration from enrollment to the patient's death (all causes)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer Resectable']}, 'descriptionModule': {'briefSummary': 'This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.', 'detailedDescription': 'The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients should be voluntary to the trial and provide with signed informed consent.\n2. Histologically confirmed diagnosis of pancreatic cancer\n3. Male or female, Age: 18-79 years old.\n4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.\n5. the value of Carbohydrate Antigen19-9(CA19-9) \\< 180U/mL within 12 weeks after surgery.\n6. No previous chemotherapy\n7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1\n8. normal function of organ system including the followings.\n\n * No hematologic dysfunction(Platelets ≥90×10\\^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).\n * Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.\n * Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).\n9. ECOG scored as 0-1.\n10. Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n1. Patient is concurrently using other antineoplastic agent.\n2. Known severe hypersensitivity to drugs in the regimen.\n3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).\n4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.\n5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.\n6. Evidence of active infection or active epidemic disease.\n7. Psychiatric illness that would prevent the patient from giving informed consent\n8. Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT04224402', 'briefTitle': 'Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.', 'orgStudyIdInfo': {'id': 'FOLFIRINOX-PC-Adjuvant'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'mFOLFIRINOX', 'description': 'Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion', 'interventionNames': ['Drug: mFOLFORINOX']}], 'interventions': [{'name': 'mFOLFORINOX', 'type': 'DRUG', 'description': 'Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.', 'armGroupLabels': ['mFOLFIRINOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yu-hong Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhong Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yuhong Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}