Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00079027
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2004-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Overall response'}, {'measure': 'Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks'}, {'measure': 'Time to progression as assessed by RECIST criteria'}, {'measure': 'Toxicity'}, {'measure': 'Health economics'}, {'measure': 'Proteomic and immunological analysis'}]}, 'conditionsModule': {'keywords': ['advanced adult primary liver cancer', 'adult primary hepatocellular carcinoma'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma (liver cancer).\n\nPURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization.\n\nSecondary\n\n* Compare the response rate in patients treated with these regimens.\n* Compare time to progression in patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the health economic implications of these regimens in these patients.\n\nOUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, stage of disease, and alpha-fetoprotein levels (\\< 500 ng/mL vs ≥ 500 ng/mL). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I (control arm): Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II (chemoembolization arm): Patients undergo transarterial chemoembolization using DC Bead and doxorubicin hydrochloride. Chemoembolization repeats every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline and at weeks 10 and 24.\n\nPatients are followed at 4 weeks and then every 12 weeks thereafter.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed hepatocellular carcinoma (HCC)\n\n * Advanced, unresectable disease\n* No clinically significant ascites\n* No modified Child-Pugh class C liver disease\n* No main portal vein occlusion/involvement\n* No extrahepatic tumor of any kind\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over (16 and over for patients residing in Scotland)\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Hemoglobin ≥ 8.5 g/dL\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin \\< 5.0 mg/dL\n* Transaminases \\< 2.5 times upper limit of normal (ULN)\n* INR \\< 1.5\n\nRenal\n\n* Creatinine \\< 2 times ULN\n\nCardiovascular\n\n* No New York Heart Association class III or IV cardiac disease\n* No acute angina\n* No significant peripheral vascular disease\n* No thrombosis of main portal vein\n* LVEF ≥ 50%\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other concurrent serious medical condition\n* No serious infection\n* No psychological, familial, sociological, or geographical factors that would preclude study compliance\n* No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior biologic therapy for advanced unresectable HCC\n\nChemotherapy\n\n* No prior systemic or regional chemotherapy\n* No prior chemotherapy for advanced unresectable HCC\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy\n\n* No prior hormonal therapy for advanced unresectable HCC\n\nRadiotherapy\n\n* No prior radiotherapy for advanced unresectable HCC\n* No other concurrent anticancer radiotherapy\n\nSurgery\n\n* More than 7 days since prior major surgery\n* More than 3 days since prior laparoscopy\n\nOther\n\n* More than 4 weeks since prior investigational agents\n* More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00079027', 'briefTitle': 'Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000353298'}, 'secondaryIdInfos': [{'id': 'CRUK-HEP-1'}, {'id': 'EU-20340'}, {'id': 'ISRCTN78345798'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'hepatic artery embolization', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cancer Research UK Clinical Trials Unit - Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8HW', 'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Haematology and Oncology Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'L69 3GA', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'W12 OHS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SO14 0YG', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal South Hants Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh at Little France', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH3 9YW', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Infirmary Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'O. J. Garden', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Infirmary of Edinburgh at Little France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham', 'class': 'OTHER'}}}}