Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT00848094
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Dose Escalation Study for Advanced Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': '1,2 and 3 years survival', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'radiation therapy', '3-dimensional conformal radiation therapy (3-DCRT)', 'intensity modulated radiation therapy (IMRT)', 'active breathing control'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Surgically unsectable or medically inoperable diseases, or surgery declined by the patient\n* Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases\n* Associated with cirrhosis of Child-Pugh A\n* Karnofsky performance status (KPS) of ≥ 70\n* Normal renal function and adequate bone marrow reservation\n* Tolerate active breathing control (ABC)\n\nExclusion Criteria:\n\n* Child-Pugh B or C liver cirrhosis score\n* Previous radiotherapy to the liver\n* Indistinct tumor boundary in CT/MRI image'}, 'identificationModule': {'nctId': 'NCT00848094', 'briefTitle': 'Radiation Dose Escalation Study for Advanced Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'LCR-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'arm 1', 'description': 'Arm I: tumor diameter more than 5 cm and less than 10 cm.', 'interventionNames': ['Radiation: 3DCRT/IMRT']}, {'type': 'OTHER', 'label': 'arm 2', 'description': 'Arm II: tumor diameter no less than 10 cm.', 'interventionNames': ['Radiation: 3DCRT/IMRT']}], 'interventions': [{'name': '3DCRT/IMRT', 'type': 'RADIATION', 'description': 'The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.', 'armGroupLabels': ['arm 1']}, {'name': '3DCRT/IMRT', 'type': 'RADIATION', 'description': 'The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II.', 'armGroupLabels': ['arm 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Guoliang Jiang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guoliang Jiang', 'oldOrganization': 'Fudan University Cancer Hospital'}}}}