Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT01736904
Status:
UNKNOWN
Last Update Posted:
2012-11-29
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
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': 'C480833', 'term': 'IFL protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-26', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival which is calculated from the start to treatment to the death', 'timeFrame': 'eight months'}], 'primaryOutcomes': [{'measure': 'Progression free survival which is calculated from the start of treatment to disease progression or death', 'timeFrame': 'eight weeks'}], 'secondaryOutcomes': [{'measure': 'Objective response rate which includes complete response(CR) and partial response(PR) participants', 'timeFrame': 'eight weeks', 'description': 'Objective response rate (ORR)= CR(complete response)+PR(partial response)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advanced colorectal cancer', 'FOLFIRI', 'XELIRI'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.', 'detailedDescription': 'The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly XELIRI regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI regimen is no less less than FOLFIRI regimen in efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.\n* Age range 18-70 years old\n* ECOG performance status 0-1\n* Life expectancy of more than 3 months\n* Adequate organ function\n\nExclusion Criteria:\n\n* Previous serious cardiac disease\n* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix\n* Pregnant or lactating women\n* chronic inflammatory bowel disease or intestinal obstruction\n* Serious uncontrolled diseases and intercurrent infection'}, 'identificationModule': {'nctId': 'NCT01736904', 'briefTitle': 'wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'wXELIRI vs FOLFIRI in CRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFIRI', 'description': 'FOLFIRI regimen', 'interventionNames': ['Drug: FOLFIRI regimen']}, {'type': 'EXPERIMENTAL', 'label': 'wXELIRI regimen', 'description': 'wXELIRI', 'interventionNames': ['Drug: wXELIRI regimen']}], 'interventions': [{'name': 'wXELIRI regimen', 'type': 'DRUG', 'otherNames': ['wXELIRI'], 'description': 'irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days', 'armGroupLabels': ['wXELIRI regimen']}, {'name': 'FOLFIRI regimen', 'type': 'DRUG', 'otherNames': ['FOLFIRI'], 'description': 'irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks', 'armGroupLabels': ['FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Li, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jin Li, PhD,MD', 'role': 'CONTACT', 'email': 'fudanlijin@163.com', 'phone': '64175590-5109'}], 'overallOfficials': [{'name': 'Jin Lin, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jin Li', 'investigatorAffiliation': 'Fudan University'}}}}