Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT00002692
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1994-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-05-20', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum', 'liver metastases'], 'conditions': ['Colorectal Cancer', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'McArdle C: IV versus IHA 5FU/leucovorin for colorectal liver metastases: preliminary results of the MRC CR05 EORTC 40972 randomised trial. [Abstract] Br J Cancer 85 (suppl 1): A-CT2. 1, 2001.'}, {'type': 'RESULT', 'citation': 'McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic (IHA) 5FU/leucovorin for colorectal (CRC) liver metastases: preliminary results of the MRC CR05/EORTC 40972 randomised trial. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-499, 2001.'}, {'type': 'RESULT', 'citation': 'McArdle C, Kerr DJ, Ledermann J, et al.: Intravenous (IV) vs intrahepatic arterial (IHA) 5-FU/leucovorin for colorectal (CRC) liver metastasis: preliminary results of the MRC CRO5/EORTC 40972 randomised trial. [Abstract] Eur J Cancer 37 (suppl 6): A-955, s257, 2001.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.', 'detailedDescription': 'OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs. intrahepatic arterial infusion of fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality of life of these patients.\n\nOUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic angiography; at laparotomy, an intrahepatic arterial catheter is fused into the gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion.\n\nPROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum with metastases confined to the liver and not amenable to surgery\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3.5 mg/dL (50 micromoles/liter) Renal: Not specified Cardiovascular: No uncontrolled heart disease (e.g., congestive heart failure, angina) Other: No uncontrolled infection No other uncontrolled medical illness\n\nPRIOR CONCURRENT THERAPY: No prior fluorouracil (5-FU) for advanced disease More than 6 months since adjuvant 5-FU (e.g., in AXIS or QUASAR studies)'}, 'identificationModule': {'nctId': 'NCT00002692', 'briefTitle': 'Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES', 'orgStudyIdInfo': {'id': 'CDR0000064434'}, 'secondaryIdInfos': [{'id': 'MRC-CR05'}, {'id': 'EU-95032'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'isolated perfusion', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'David J. Kerr, MD, FRCP, DSc', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}}}}