Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT03443661
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2018-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509829', 'term': 'FOLFOXIRI protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2018-01-14', 'studyFirstSubmitQcDate': '2018-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR', 'timeFrame': '1 year', 'description': 'Pathological complete response according to Mandard tumor regression grading'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '1 year', 'description': 'R0 resection rate'}, {'measure': 'locoregional recurrence rate', 'timeFrame': '1 year', 'description': 'locoregional recurrence rate'}, {'measure': 'Safety', 'timeFrame': '1 year', 'description': 'Including adverse events during neoadjuvant chemotherapy,surgery and perioperative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['5-Fluorouracil', 'rectal cancer', 'irinotecan', 'oxaliplatin', 'neoadjuvant chemotherapy'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37370032', 'type': 'DERIVED', 'citation': 'Zhang W, Zhou H, Jiang J, Zhu Y, Zou S, Jiang L, Tang Y, Liang J, Sun Y, Jiang Z, Qu W, Li Y, Zhou A. Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial. BMC Cancer. 2023 Jun 27;23(1):592. doi: 10.1186/s12885-023-11103-x.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced rectal cancer', 'detailedDescription': 'In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years) with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is : oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled 4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were feasibility, safety, tolerance and efficacy of neoadjuvant treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed locally advanced rectal cancer;\n2. 18-70 years ；\n3. Clinicalstage:T3,4a,N0,M0;T1-4a,N+,M0;\n4. Tumor from anus \\>5cm and ≤15cm;\n5. ECOG=0-1;\n6. Available organ function:ALT≤1.5xULN;AST≤1.5xULN;TBIL≤1.0xULN; NEUT≥2×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;\n7. Informed consent;\n8. UGT1A1:UGT1A1\\*1/UGT1A1\\*1,UGT1A1\\*1/UGT1A1\\*28,UGT1A1\\*1/UGT1A1\\*6;\n\nExclusion Criteria:\n\n1. Clinical stage T4b or unresectable disease;\n2. History of pelvic radiotherapy;\n3. History of chemotherapy within 5 years;\n4. History of chronic diarrhea;\n5. Tumor causes intestinal obstruction, intestinal perforation, and severe bleeding;\n6. Hepatitis B surface antigen positive; Hepatitis C virus infection; Cirrhosis of the liver for any cause;\n7. UGT1A1:UGT1A1\\*28/UGT1A1\\*28,UGT1A1\\*6/UGT1A1\\*6;\n8. Other cancers in the past 5 years, except for cervical carcinoma in situ or non-melanoma skin cancer;\n9. Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure; interstitial pneumonia,pulmonary fibrosis, uncontrolled diabetes, renal insufficiency;\n10. Mental illness;Pregnant or lactating women;'}, 'identificationModule': {'nctId': 'NCT03443661', 'briefTitle': 'Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'A Pilot Phase II Study of Neoadjuvant Triplet Chemotherapy Regimen （FOLFOXIRI） in Patients With Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': 'CH-GI-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFOXIRI', 'description': 'oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals', 'interventionNames': ['Drug: FOLFOXIRI']}], 'interventions': [{'name': 'FOLFOXIRI', 'type': 'DRUG', 'description': 'oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals', 'armGroupLabels': ['FOLFOXIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Aiping Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aiping Zhou', 'class': 'UNKNOWN'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Aiping Zhou', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}