Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT03504618
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2018-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509829', 'term': 'FOLFOXIRI protocol'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' characteristic", 'timeFrame': '4 years', 'description': 'Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable'}, {'measure': 'Response rate after 3 cycles', 'timeFrame': 'At the end of Cycle 3 (each cycle is 4 weeks)', 'description': 'Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.'}, {'measure': 'Response rate after 6 cycles', 'timeFrame': 'At the end of Cycle 6 (each cycle is 4 weeks)', 'description': 'Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.'}, {'measure': 'Correlation between response rate and percentage of chemotherapy dosage', 'timeFrame': '4 years', 'description': 'Prognostic factor of response rate'}, {'measure': 'Correlation between response rate and histopathology', 'timeFrame': '4 year', 'description': 'Prognostic factor of response rate'}, {'measure': 'Correlation between response rate and metastatic site', 'timeFrame': '4 years', 'description': 'The average size of the hepatic metastatic lesion in the study'}, {'measure': 'Prognostic factor for response rate after 3 cycles', 'timeFrame': 'At the end of cycle 3 (each cycle is 4 weeks)', 'description': 'Evaluation of predictor of response rate'}, {'measure': 'Prognostic factor for response rate after 6 cycles', 'timeFrame': 'At the end of cycle 6 (each cycle is 4 weeks)', 'description': 'Evaluation of predictor of response rate'}, {'measure': 'Mean of the progression free survival', 'timeFrame': '4 years', 'description': 'The median progression free survival of the study population'}, {'measure': 'Prognostic factor of progression free survival', 'timeFrame': '4 years', 'description': 'Evaluation of predictor of progression free survival'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '4 years', 'description': 'During the full length of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria latest version.'}, {'measure': 'Overall survival after 12 months', 'timeFrame': '12 months after the last patient finish chemotherapy', 'description': 'The percentage of survival patients 12 month after finishing treatment with FOLFOXIRI regimen'}, {'measure': 'Overall survival after 24 months', 'timeFrame': '24 months after the last patient finish chemotherapy', 'description': 'The percentage of survival patients 24 month after finishing treatment with FOLFOXIRI regimen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.\n\nThe second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients', 'detailedDescription': 'In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.\n\nAccording to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.\n\nIn VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients recruited to the study will be explained in detail will be required to sign a volunteer card. All detailed information on the patient's medical condition is encrypted and confidential. The patient has the right to withdraw from the study", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017'}, 'identificationModule': {'nctId': 'NCT03504618', 'briefTitle': 'Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI', 'organization': {'class': 'OTHER', 'fullName': 'Hanoi Medical University'}, 'officialTitle': 'Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI Regimen (Folinic Acid, 5-fluorouracil, Oxaliplatin and Irinotecan)', 'orgStudyIdInfo': {'id': 'HMU16223'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metastatic colon cancer patients', 'description': 'Colon cancer patients with metastase at the diagnostic time, impossibility of radical resection, adenocarcinoma, treated by at least 3 cycles of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department', 'interventionNames': ['Drug: FOLFOXIRI']}], 'interventions': [{'name': 'FOLFOXIRI', 'type': 'DRUG', 'description': 'Treatment of FOLFOXIRI regimen at first line with dosage:\n\nIrinotecan: 165 mg / m2, intravenous infusion for 1 hour. Day 1, 15. Oxaliplatin: 85 mg / m2, intravenously for 2 hours Day 1, 15 Calcium folinate 200 mg / m2, intravenously for 2 hours Day 1, 15 5FU 3200 mg / m 2, intravenous infusion continuously for 48 hours Day 1, 2, 3, 15, 16, 17 Every 4 weeks. Each cycle has 2 infusion times, the first one is the first day, the second one is the 15th day', 'armGroupLabels': ['Metastatic colon cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Hanoi Medical University', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanoi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Science Research and International Cooperation Unit', 'investigatorFullName': 'Bui My Hanh', 'investigatorAffiliation': 'Hanoi Medical University'}}}}