Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02228356
Status:
UNKNOWN
Last Update Posted:
2016-05-11
First Post:
2014-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], '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'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2014-08-22', 'studyFirstSubmitQcDate': '2014-08-26', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One year local control', 'timeFrame': 'one year post radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Acute toxicity', 'timeFrame': 'Up to 3 months post radiotherapy'}, {'measure': 'Survival', 'timeFrame': '3 to 36 months post Radiotherapy', 'description': 'Overall survival'}, {'measure': 'Progression Free Survival', 'timeFrame': '3 to 36 months post Radiotherapy'}, {'measure': 'Late toxicity', 'timeFrame': '3 to 36 months post Radiotherapy'}]}, 'conditionsModule': {'keywords': ['Neoplasm Metastasis', 'oligometastatic cancer', 'Stereotactic Body Radiation Therapy', 'SBRT', 'Real-time Tumor Tracking (RTTT)', 'ITV', 'Internal Target Volume', 'Respiratory Motion Management', 'Image-guided Radiotherapy', 'IGRT'], 'conditions': ['Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '20685718', 'type': 'BACKGROUND', 'citation': 'Engels B, Everaert H, Gevaert T, Duchateau M, Neyns B, Sermeus A, Tournel K, Verellen D, Storme G, De Ridder M. Phase II study of helical tomotherapy for oligometastatic colorectal cancer. Ann Oncol. 2011 Feb;22(2):362-8. doi: 10.1093/annonc/mdq385. Epub 2010 Aug 4.'}, {'pmid': '22423615', 'type': 'BACKGROUND', 'citation': 'Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.'}]}, 'descriptionModule': {'briefSummary': 'The investigators recently published 2 phase II trials on the use of helical tomotherapy for oligometastatic colorectal cancer \\[1,2\\]. Despite a dose increase from 40 to 50 Gy, delivered in 2 weeks time, the one-year local control was 54% only \\[1,2\\]. The high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (BED) of \\< 100 Gy. The current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated CT to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a Monte Carlo or collapsed cone dose calculation algorithm delivering 50 Gy to the 80% isodose, allowing higher doses in the tumor core. As the concept of an internal target volume (ITV) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the VERO SBRT system will be applied in those patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic cancer from any primary origin and no more than 5 metastases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with metastatic cancer from any primary origin and no more than 5 metastases on CT--scan\n2. Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)\n3. Functional liver volume \\> 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (DLCO) of \\> 30% if lung mets\n4. No Child B or C liver cirrhosis\n5. No systemic treatment within 1 month before initiation of radiotherapy\n6. No contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (OAR))\n7. No metastases from another carcinoma\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n9. Age \\> 18 years'}, 'identificationModule': {'nctId': 'NCT02228356', 'briefTitle': 'Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Non-interventional Observational Study of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Cancer', 'orgStudyIdInfo': {'id': 'BUN143201215117'}, 'secondaryIdInfos': [{'id': 'BUN143201215117', 'type': 'REGISTRY', 'domain': 'UZ Brussel Ethics Committee'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Stereotactic Body Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Vero', 'Tomotherapy'], 'description': 'Stereotactic Body Radiation Therapy with either Dynamic Tumor Tracking/Internal Target Volume approach on the Vero machine, and/or Internal Target Volume approach on the Tomotherapy machine.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Benedikt Engels, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark De Ridder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robbe Van Den Begin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Harijati Versmessen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UZ Brussel Radiotherapie dienst', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'centralContacts': [{'name': 'Benedikt Engels, MD, PhD', 'role': 'CONTACT', 'email': 'benedikt.engels@uzbrussel.be', 'phone': '+324776041'}, {'name': 'Cleo Wauters, MD', 'role': 'CONTACT', 'email': 'cleo.wauters@uzbrussel.be', 'phone': '+324776041'}], 'overallOfficials': [{'name': 'Benedikt Engels, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel'}, {'name': 'Robbe Van den Begin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel'}, {'name': 'Mark De Ridder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dienst Radiotherapie, UZ Brussel, Vrije Universiteit Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Benedikt Engels, MD, PhD', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}