Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-28 @ 4:20 PM
Study NCT ID:
NCT01823003
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'probability of not suffering a grade 3 or higher toxicity', 'timeFrame': 'one year', 'description': 'Patients will be follow-up during one year. If patient suffered any toxicity grade 3 or higher during this period it will be classified as having toxicity. Otherwise patient will be classified as not having toxicity.'}], 'secondaryOutcomes': [{'measure': 'Tumour response', 'timeFrame': 'One year', 'description': 'To evaluate tumour response attending histology with local radiation using imaging such as CT and PET/CT.'}, {'measure': 'Incidence of acute and late toxicities', 'timeFrame': 'One year', 'description': 'To evaluate the frequency of acute and late toxicities.'}, {'measure': 'Overall survival', 'timeFrame': 'One year', 'description': 'To evaluate the impact of local therapy on overall survival.'}, {'measure': 'Disease-free survival', 'timeFrame': 'One year', 'description': 'To evaluate the impact of local therapy on disease-free survival.'}, {'measure': 'Effect in brochopulmonary (COPD) disease.', 'timeFrame': 'One year', 'description': 'To evaluate the impact of local therapy on bronchopulmonary (COPD) disease.'}, {'measure': 'Feasibility', 'timeFrame': 'One year', 'description': 'To evaluate the feasibility of this technique in terms of technical complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carcinoma, Non-Small-Cell Lung', 'Neoplasm Metastasis', 'Radiosurgery'], 'conditions': ['Carcinoma, Non-Small-Cell Lung', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety of Stereotactic Ablative Radiotherapy (SBRT) in selected patients with stage I Non Small Cell Lung Cancer (NSCLC) or metastatic lung cancer to demonstrate the feasibility and risks of using an ablative dose-adapted scheme with FFF beams. Other aims are To evaluate the incidence of acute and late complications; To evaluate tumour response to local radiation therapy by means of CT, PET/TC and MRI and To evaluate the impact of local therapy on overall and disease-free survival.', 'detailedDescription': 'The intervention (dose and fractions) depends on topographical parameters: lung disease (primary, peripheral nodes or mediastinal nodes), distance to chest wall, tumour size and distance to main bronchus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically-confirmed primary lung cancer or lung metastasis from another primary tumour or positive PET/CT suggestive for primary tumour(SUV MAX\\> 4).\n* Tumour size \\< 5 cm in diameter prior to treatment.\n* Medically inoperable patients as determined by the multidisciplinary thoracic tumour board, or medically operable patients who refuse surgery.\n* Life expectancy of \\>12 months.\n* Criterion for medical inoperability include:\n\nOverall clinical assessment at the UCLA thoracic tumour board. Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below: Minor Criteria: Age \\> 75, FEV1 51- 60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \\< 40% or less), resting or exercise arterial pO2 \\< 55 mmHg, and pCO2 \\> 45 mmHg.\n\n* Age \\> 18 years.\n* KPS \\> 70.\n* Barthel score \\>40\n* Baseline computed tomography scans of the chest, pulmonary test function, and positron emission tomography no more than 2 months before treatment.\n* If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior thoracic radiation treatment wich dose contribution can be expected in the new SBRT plan.\n* More than two lesions per lobe.\n* Active infections requiring systemic antibiotics.\n* Age \\<18 years old.\n* KPs \\< 70.\n* Barthel Total Score \\< 40.'}, 'identificationModule': {'nctId': 'NCT01823003', 'acronym': 'sbrtlungfff', 'briefTitle': 'Risk Adapted SABR(SABR) in Stage I NSCLC And Lung Metastases', 'organization': {'class': 'OTHER', 'fullName': "Institut Català d'Oncologia"}, 'officialTitle': 'Risk Adapted Free Flattering Filter Based Stereotactic Ablative Radiotherapy (Sabr) in Stage i Nsclc and Lung Metastases', 'orgStudyIdInfo': {'id': 'sbrt_lung_fff2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A. 34 Gy in a single fraction', 'description': '34 Gy by single fraction Risk-adapted radiation dose.', 'interventionNames': ['Radiation: 34 Gy in a single fraction']}, {'type': 'EXPERIMENTAL', 'label': 'B. 54Gy (18Gy/fr. x 3 fractions)', 'description': '54Gy administered in 3 fraction of 18 Gy, risk adapted radiation dose', 'interventionNames': ['Radiation: 54Gy 18Gy/fr. x 3 fractions']}, {'type': 'EXPERIMENTAL', 'label': 'C. 50Gy (12 x 5 fr.s)', 'description': '54Gy administered in 5 fraction of 12 Gy, risk adapted radiation dose', 'interventionNames': ['Radiation: 60Gy (12 x 5 fr.s)']}, {'type': 'EXPERIMENTAL', 'label': 'D. 60Gy (7.5Gy x 8fr.)', 'description': '60 Gy administered in 8 fraction of 7.5 Gy, risk adapted radiation dose', 'interventionNames': ['Radiation: 60Gy (7.5Gy x 8fr.)']}], 'interventions': [{'name': '34 Gy in a single fraction', 'type': 'RADIATION', 'description': '34 Gy in a single fraction in case of Distance to chest wall \\> 1 cm, tumour size \\< 2 cm and distance to the main bronchus \\> 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.', 'armGroupLabels': ['A. 34 Gy in a single fraction']}, {'name': '54Gy 18Gy/fr. x 3 fractions', 'type': 'RADIATION', 'description': '54Gy administered in 3 fractions of 18Gy in case of distance to chest wall \\> 1 cm, tumour size between 2 and 5 cm and distance to the main bronchus \\> 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.', 'armGroupLabels': ['B. 54Gy (18Gy/fr. x 3 fractions)']}, {'name': '60Gy (12 x 5 fr.s)', 'type': 'RADIATION', 'description': '50Gy administered in 5 fractions of 12 Gy for Peripheral Nodes in case of distance to chest wall \\< 1 cm, tumour size \\< 5 cm and distance to main bronchus \\> 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.', 'armGroupLabels': ['C. 50Gy (12 x 5 fr.s)']}, {'name': '60Gy (7.5Gy x 8fr.)', 'type': 'RADIATION', 'description': '60 Gy administered in 8 fractions of 7.5 Gy for mediastinal nodes in case of tumour size \\< 5 cm and distance to the main bronchus \\< 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.', 'armGroupLabels': ['D. 60Gy (7.5Gy x 8fr.)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Institut Català d'Oncologia - L'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Arturo Navarro-Martin, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut Català d'Oncologia L'Hospitalet"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Català d'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}