Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT04512833
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival time', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 36 months', 'description': 'OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.'}, {'measure': 'Progression-free survival time', 'timeFrame': 'From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months', 'description': 'PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.'}, {'measure': 'Local control time', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months', 'description': 'LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.'}], 'secondaryOutcomes': [{'measure': 'Radiation-induced liver injury rates', 'timeFrame': 'From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.'}, {'measure': 'Adverse reaction', 'timeFrame': 'From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'CyberKnife', 'stereotactic body radiation therapy', 'Child-Pugh B classification', 'Child-Pugh C classification'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '32158688', 'type': 'RESULT', 'citation': 'Sun J, Zhang A, Li W, Wang Q, Wang J, Fan Y, Sun Y, Li D, Zhang D, Duan X. CyberKnife Stereotactic Body Radiation Therapy as an Effective Treatment for Hepatocellular Carcinoma Patients With Decompensated Cirrhosis. Front Oncol. 2020 Feb 25;10:100. doi: 10.3389/fonc.2020.00100. eCollection 2020.'}, {'pmid': '24906626', 'type': 'RESULT', 'citation': 'Culleton S, Jiang H, Haddad CR, Kim J, Brierley J, Brade A, Ringash J, Dawson LA. Outcomes following definitive stereotactic body radiotherapy for patients with Child-Pugh B or C hepatocellular carcinoma. Radiother Oncol. 2014 Jun;111(3):412-7. doi: 10.1016/j.radonc.2014.05.002. Epub 2014 Jun 3.'}, {'pmid': '28214411', 'type': 'RESULT', 'citation': 'Granito A, Bolondi L. Non-transplant therapies for patients with hepatocellular carcinoma and Child-Pugh-Turcotte class B cirrhosis. Lancet Oncol. 2017 Feb;18(2):e101-e112. doi: 10.1016/S1470-2045(16)30569-1.'}, {'pmid': '20879569', 'type': 'RESULT', 'citation': 'Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.'}, {'pmid': '26028227', 'type': 'RESULT', 'citation': 'Huertas A, Baumann AS, Saunier-Kubs F, Salleron J, Oldrini G, Croise-Laurent V, Barraud H, Ayav A, Bronowicki JP, Peiffert D. Stereotactic body radiation therapy as an ablative treatment for inoperable hepatocellular carcinoma. Radiother Oncol. 2015 May;115(2):211-6. doi: 10.1016/j.radonc.2015.04.006. Epub 2015 May 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our research is to evaluate the curative effect and safety of CyberKnife stereotactic body radiation therapy in treating small hepatocellular carcinoma (HCC) patients with decompensated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The small HCC patients with decompensated cirrhosis who refused or were ineligible for other treatments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology\n* Unfeasible or refusing to undergo other treatments;\n* Residual normal liver volume ≥700 cc;\n* With decompensated cirrhosis (Child-Pugh B or C classification);\n* Without portal vein tumor thrombus;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1;\n* Distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm；\n* Rejecting other therapies such as resection, liver transplantation, etc.\n* Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;\n* Patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.\n\nExclusion Criteria:\n\n* With Tumor thrombus；\n* With extrahepatic metastasis;\n* With lymph node involvement.'}, 'identificationModule': {'nctId': 'NCT04512833', 'briefTitle': 'CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma Patients With Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'CyberKnife Stereotactic Body Radiation Therapy for Small Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'decompensated cirrhosis HCC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cyberknife stereotactic body radiation therapy', 'type': 'RADIATION', 'description': 'A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuezhang Duan', 'role': 'CONTACT', 'email': 'duanxuezhang2006@163.com', 'phone': '+8613621386161'}], 'facility': 'Beijing 302 hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jing Sun', 'role': 'CONTACT', 'email': '519299998@qq.com', 'phone': '+8613718681094'}, {'name': 'Xuezhang Duan', 'role': 'CONTACT', 'email': 'duanxuezhang2006@163.com', 'phone': '+8613621386161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}