Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-01 @ 9:35 AM
Study NCT ID:
NCT01465451
Status:
UNKNOWN
Last Update Posted:
2016-08-11
First Post:
2011-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 695}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-10', 'studyFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2011-11-03', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '3 years', 'description': '3 years survival of recurrence-free, metastasisi-free, death-free after randomization.'}], 'secondaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '5 years', 'description': '5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.'}, {'measure': 'safety profiles', 'timeFrame': '28 days after randomization', 'description': 'complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer', 'curative resection', 'intra-operative chemotherapy', '5-fluorouracil', 'chemotherapy'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '28849265', 'type': 'DERIVED', 'citation': 'Zhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed as adenocarcinoma of colon and rectum\n* age 18-75 years\n* eligible for curative surgical resection\n* performance score: ECOG 0-1\n* normal blood cells counts: WBC ≥ 4.0×10\\*9/L，PLT ≥ 100×10\\*9/L\n* normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN\n* normal ECG\n* no history of other malignant tumors\n* no concomitant anti-cancer therapy\n\nExclusion Criteria:\n\n* clinical bowel obstruction\n* anticipated into another clinical trial within three months\n* uncontrolled infection, serious internal medical diseases\n* Pregnant or lactating women\n* mentally abnormal patients\n* patients known allergic to 5-FU'}, 'identificationModule': {'nctId': 'NCT01465451', 'acronym': 'IOCCRC', 'briefTitle': 'Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer', 'orgStudyIdInfo': {'id': 'SYSU 5010-2010016 IOCCRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARM A- surgery alone', 'description': 'all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy.', 'interventionNames': ['Procedure: curative resection for colorectal cancer']}, {'type': 'EXPERIMENTAL', 'label': 'ARM B surgery plus chemotherapy', 'description': 'all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation.', 'interventionNames': ['Procedure: curative resection for colorectal cancer', 'Drug: intra-operative 5-FU chemotherapy']}], 'interventions': [{'name': 'curative resection for colorectal cancer', 'type': 'PROCEDURE', 'otherNames': ['curative resection for colorectal cancer.'], 'description': 'right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer.', 'armGroupLabels': ['ARM A- surgery alone', 'ARM B surgery plus chemotherapy']}, {'name': 'intra-operative 5-FU chemotherapy', 'type': 'DRUG', 'otherNames': ['intra-operative 5-FU chemotherapy for colorectal cancer'], 'description': '5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction.\n\n5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A.', 'armGroupLabels': ['ARM B surgery plus chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'zhizhong pan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director, M.D., Ph.D', 'investigatorFullName': 'ZHI-ZHONG PAN', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}