Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 7:10 PM
Study NCT ID:
NCT03603834
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2018-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of overall response evaluated by MRI or CT', 'timeFrame': 'Up to 15 weeks', 'description': 'The rate of response evaluated by MRI or CT according to RECIST 1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Resectability rate', 'timeFrame': 'Up to 24 weeks', 'description': 'The rate of patients who can successfully undergo surgery after chemotherapy'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'every 15 days for approximately 24 weeks', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant', 'Potentially resectable', 'Chemotherapy', 'Bile duct cancer'], 'conditions': ['Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma. This study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.', 'detailedDescription': 'Previous reports suggest benefit of neoadjuvant chemotherapy/chemoradiation treatment for borderline resectable cholangiocarcinoma.\n\nThis study is a single center prospective phase II study of neoadjuvant chemotherapy with mFOLFOXIRI in patients with borderline resectable cholangiocarcinoma.\n\nThis phase 2 trial was designed to enroll 25 patients with BRCC who were assigned to mFOLFOXIRI neoadjuvant chemotherapy. The primary endpoint was the overall response rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Diagnosed with cholangiocarcinoma and the disease is measurable by RECIST 1.1 criteria\n3. ECOG performance status of 0 or 1\n4. No distant metastasis\n5. The disease is either resectable or potentially resectable\n6. Patients must have adequate organ function as defined by the following laboratory values at study entry:\n\n Hemoglobin ≥ 8 g/dL (transfusions are acceptable) ANC ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L AST/ALT ≤ 3 x ULN Total bilirubin ≤ 2.5 mg/dL Creatinine clearance ≥ 50 mL/min (estimated by Cockcroft-Gault or measured)\n7. Women of childbearing potential definition (WOCBP) and men must agree to use adequate contraception prior, to study entry, for the duration of study participation, and 3 months after the end of treatment.\n8. WOCBP must have a negative serum or urine pregnancy test prior to initiation of treatment.\n\nExclusion Criteria:\n\n1. \\> 75 years old\n2. Prior therapy for cholangiocarcinoma with either surgery, radiation or chemotherapy\n3. Other malignancies except for the following: adequately treated cervical carcinoma in situ and treated basal cell carcinoma.\n4. Hypersensitivity to 5FU, oxaliplatin (or other platinum agents), irinotecan (or to their excipients).\n5. Pregnant or lactating women.\n6. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n7. Liver disease including but not limited to cirrhosis, primary sclerosing cholangitis, future liver remnant of less than 20-30%\n8. Comorbidity including but not limited to active clinically serious infections, congestive heart failure, life-threatening arrhythmia\n9. known HIV positive\n10. Baseline peripheral neuropathy/paresthesia grade ≥ 2.'}, 'identificationModule': {'nctId': 'NCT03603834', 'briefTitle': 'Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Prospective Phase II Study of Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma', 'orgStudyIdInfo': {'id': 'HE611336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mFOLFOXIRI', 'description': 'mFOLFOXIRI consists of the following combination of drugs:\n\nOxaliplatin, 85 mg/m2, IV over 2 hours Leucovorin, 400 mg/m2, IV over 2 hours Irinotecan, 150 mg/m2, IV over 90 minutes 5 FU, 400 mg/m2, IV bolus 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection\n\neach 14 day cycle, for 6 cycles', 'interventionNames': ['Drug: mFOLFOXIRI']}], 'interventions': [{'name': 'mFOLFOXIRI', 'type': 'DRUG', 'otherNames': ['Oxaliplatin', 'Irinotecan', 'Fluorouracil', 'Leucovorin'], 'description': 'mFOLFOXIRI consists of the following combination of drugs:\n\n1. Oxaliplatin, 85 mg/m2, IV over 2 hours\n2. Leucovorin, 400 mg/m2, IV over 2 hours\n3. Irinotecan, 150 mg/m2, IV over 90 minutes\n4. 5 FU, 400 mg/m2, IV bolus\n5. 5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection\n\neach 14 day cycle, for 6 cycles', 'armGroupLabels': ['mFOLFOXIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Jureerat Ratanaphet, Master', 'role': 'CONTACT', 'email': 'jurepr@kku.ac.th', 'phone': '6643366592'}, {'name': 'Jarin Chindaprasirt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aumkhae Sookprasert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kosin Wirasorn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Attapol Titapun, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kulyada Somsap, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Watcharin Loilome, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Narong Kuntikheo, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jarin Chindaprasirt', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'centralContacts': [{'name': 'Jarin Chindaprasirt, MD', 'role': 'CONTACT', 'email': 'jarich@kku.ac.th', 'phone': '6643366562'}, {'name': 'Jaruda Sringam, Master', 'role': 'CONTACT', 'email': 'talnurse8@gmail.com', 'phone': '6643366562'}], 'overallOfficials': [{'name': 'Jarin Chindaprasirt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jarin Chindaprasirt', 'investigatorAffiliation': 'Khon Kaen University'}}}}