Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-03-12 @ 7:02 PM
Study NCT ID:
NCT06341257
Status:
WITHDRAWN
Last Update Posted:
2025-04-09
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Toxicity of SCART
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participant', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Control (LC)', 'timeFrame': 'From date of radiotherapy until the date of first documented progression, assessed up to 60 months', 'description': 'a tumor volume equal to or less than the tumor volume at start of radiotherapy'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From date of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months', 'description': 'the time from inclusion to disease progression or death from any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bulky tumor', 'Palliative radiotherapy', 'Stereotactic Central/Core Ablative Radiation Therapy', 'Efficacy', 'Toxicity'], 'conditions': ['Tumor Size Greater Than or Equal to 5 cm']}, 'referencesModule': {'references': [{'pmid': '19997074', 'type': 'BACKGROUND', 'citation': 'Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* ECOG score ≤ 2, pathological confirmation of cancer diagnosis\n* Pathologically proved malignant tumor with a maximum diameter greater than or equal to 5 cm\n* One or more lesions, not suitable for surgery\n* Patient has provided informed consent\n\nExclusion Criteria:\n\n* Pregnant\n* Life expectancy less than six months\n* Uncontrolled angina, arrythmia, and congestive heart failure\n* History of malignant pleural effusion'}, 'identificationModule': {'nctId': 'NCT06341257', 'briefTitle': 'Efficacy and Toxicity of SCART', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Efficacy and Toxicity of Stereotactic Central/Core Ablative Radiation Therapy (SCART) - A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'VGHTCCTC_SCART001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCART', 'description': 'The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor GTV boundary.', 'interventionNames': ['Radiation: Stereotactic Central/Core Ablative Radiation Therapy (SCART)']}], 'interventions': [{'name': 'Stereotactic Central/Core Ablative Radiation Therapy (SCART)', 'type': 'RADIATION', 'description': 'The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor GTV boundary.', 'armGroupLabels': ['SCART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '407', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Hao-Shen Cheng', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}