Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-02 @ 12:54 PM
Study NCT ID:
NCT07121335
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMC Radiation Oncology SABR Cohort for Oligometastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood (20 mL) will be collected and retained for future DNA extraction and biomarker analyses, including circulating tumor DNA (ctDNA) profiling.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.', 'description': 'Time from the start of stereotactic body radiotherapy (SABR) to the first documented event of local failure, distant failure, death from any cause, or last follow-up, whichever occurs first.'}, {'measure': 'Physician assessed toxicity', 'timeFrame': '1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.', 'description': 'Evaluated by treating physician based on CTCAE ver 5.0'}, {'measure': 'Patient-reported outcome', 'timeFrame': '1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.', 'description': 'It will be measured by PRO-CTCAE coreset 12.'}, {'measure': 'Local failure', 'timeFrame': '1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.', 'description': 'Local regrowth or progression at the site of SABR.'}, {'measure': 'Dynamics of ctDNA', 'timeFrame': 'It will be collected 1-week before SABR and 4-6 weeks after SABR.', 'description': 'ctDNA analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic body radiotherapy', 'Oligometastasis', 'Oligoprogression', 'ctDNA'], 'conditions': ['Stereotactic Body Radiation Therapy (SBRT)', 'Oligometastasis', 'Oligoprogression', 'ctDNA', 'Patient-Reported Outcomes (PRO)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.\n\nThe main questions it aims to answer are:\n\n1. oncologic outcomes (progression-free survival, local failure rate),\n2. patient-reported outcomes,\n3. physician-assessed toxicity, and\n4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performance status (ECOG PS) 0-2\n* Diagnosed with metastatic disease\n* Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)\n\nExclusion Criteria:\n\n* Patient with a history of prior radiotherapy to the site planned for SABR\n* Patients with concomitant brain metastases'}, 'identificationModule': {'nctId': 'NCT07121335', 'acronym': 'SABR-OMOP', 'briefTitle': 'SMC Radiation Oncology SABR Cohort for Oligometastasis', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer', 'orgStudyIdInfo': {'id': 'SMC 2025-03-037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stereotactic body radiotherapy (SBRT)', 'type': 'RADIATION', 'description': 'Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nalee Kim', 'role': 'CONTACT', 'email': 'nalee.kim@samsung.com', 'phone': '82-2-3410-2612'}], 'facility': 'Samsung medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Nalee Kim, MD, PhD', 'role': 'CONTACT', 'email': 'nalee.kim@samsung.com', 'phone': '82-2-3410-2612'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Nalee Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}