Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 8:34 PM
Study NCT ID:
NCT00764595
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '7.5 years', 'description': 'Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first.'}], 'secondaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': '48 weeks', 'description': 'Tumor response is defined as best overall response by RECIST v1.0 from date of starting protocol treatment until 48 weeks after starting protocol treatment.'}, {'measure': 'Overall survival', 'timeFrame': '7.5 years', 'description': 'Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.'}, {'measure': 'Types and severities of adverse events', 'timeFrame': '7.5 years', 'description': 'Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastrointestinal stromal tumor', 'liver metastases'], 'conditions': ['Gastrointestinal Stromal Tumor', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.', 'detailedDescription': 'OBJECTIVES:\n\n* To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of gastrointestinal stromal tumor (GIST)\n* Hepatic metastasis meeting the following criteria:\n\n * No more than 3 hepatic metastases\n * Clinically diagnosed as surgically resectable with no macroscopic residual tumor\n * Synchronous hepatic metastasis allowed provided primary tumor is also resectable\n* No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease\n* No extrahepatic metastasis\n* No history of GIST recurrence\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* Leukocyte count ≥ 3,000/μL\n* Neutrophil count ≥ 1,500/μL\n* Hemoglobin ≥ 8.0 g/dL\n* Platelet count ≥ 75,000/μL\n* Total bilirubin ≤ 2.0 mg/dL\n* ALT and AST \\< 120 IU/L\n* GTP \\< 210 IU/L\n* Not pregnant\n* No poorly controlled diabetes mellitus\n* No NYHA class III-IV cardiac function\n* No hepatitis B or hepatitis B carriers\n* No other malignancy requiring treatment\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior imatinib mesylate\n* No prior interventional radiology for metastatic disease\n* No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions'}, 'identificationModule': {'nctId': 'NCT00764595', 'acronym': 'GISTs', 'briefTitle': 'Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)', 'orgStudyIdInfo': {'id': 'CDR0000615628'}, 'secondaryIdInfos': [{'id': 'NIIGATAU-TRIGIST0805', 'type': 'OTHER', 'domain': 'Niigata University Medical and Dental Hosptial'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'imatinib mesylate', 'description': 'All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient.', 'interventionNames': ['Drug: imatinib mesylate']}], 'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG', 'description': 'Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.', 'armGroupLabels': ['imatinib mesylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Cancer Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '480-1195', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi Medical University', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '036-8562', 'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Hirosaki University, School of Medicine', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '737-0023', 'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'National Hospital Organization Kure Medical Center', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '241-0815', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Cancer Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '245-0006', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'International Goodwill Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '783-8505', 'city': 'Nankoku', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Medical School', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}, {'zip': '602-8026', 'city': 'Kanigyou-ku', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Second Red Cross Hospital'}, {'zip': '889-1692', 'city': 'Kiyotake', 'state': 'Miyazaki', 'country': 'Japan', 'facility': 'University of Miyazaki Hospital'}, {'zip': '943-0192', 'city': 'Jōetsu', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Prefectural Central Hospital', 'geoPoint': {'lat': 37.14828, 'lon': 138.23642}}, {'zip': '940-8653', 'city': 'Nagaoka', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Nagaoka Chuo General Hospital', 'geoPoint': {'lat': 37.45, 'lon': 138.85}}, {'zip': '879-5593', 'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Oita University Hospital', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'zip': '701-01', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kawasaki Medical School', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '903-0215', 'city': 'Nishiharacho', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'Ryukyu University Hospital'}, {'zip': '590-0064', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Sakai Municipal Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '560-8565', 'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Toyonaka Municipal Hospital', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '350-1241', 'city': 'Hidaka', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University International Medical Center', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu University School of Medicine', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '409-3898', 'city': 'Chūō', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'University of Yamanashi Hospital', 'geoPoint': {'lat': 35.59465, 'lon': 138.50275}}, {'zip': '812-8582', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960-1295', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '890-8520', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Kagoshima University', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '292-8535', 'city': 'Kisarazu', 'country': 'Japan', 'facility': 'Kimitsu Chuo Hospital', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'zip': '781-8555', 'city': 'Kochi', 'country': 'Japan', 'facility': 'Kochi Health Sciences Center', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '860-8556', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '951-8510', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata University Medical and Dental Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '951-8566', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Cancer Center Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '700-8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '410-2295', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Juntendo University Shizuoka Hospital', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '411-8777', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '770-8503', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'Tokushima University Hospital', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '113-0021', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan - Komagome Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-8582', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '930-0194', 'city': 'Toyama', 'country': 'Japan', 'facility': 'Toyama University Hospital', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}], 'overallOfficials': [{'name': 'Tatsuo Kanda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Niigata University Medical & Dental Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Niigata University Medical & Dental Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}