Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-05 @ 1:21 PM
Study NCT ID:
NCT01933568
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2013-08-28', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.', 'timeFrame': '2 yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inoperable Locally Advanced Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '31431387', 'type': 'DERIVED', 'citation': 'Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival', 'detailedDescription': 'In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors \\< 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is \\< 5 cm).\n* Weight loss \\< 10% in the last three months\n* WHO-performance status ≤ 2\n* Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine\n* FEV1 and DLCO \\> 40 % of the age-adjusted normal value\n* Minimum required laboratory data bone marrow reserve and hepatic- and renal function\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Before patient registration, written informed consent must be given according to GCP and national regulations\n\nExclusion criteria:\n\n* Patients with central tumors \\< 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.\n* Patients that receive sequential chemoradiotherapy or radiotherapy only.\n* Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)\n* Patients with Pancoast tumors\n* Prior radiotherapy treatment to the thorax\n* Any contraindications to the administration of thoracic radiotherapy\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01933568', 'acronym': 'N12HYB', 'briefTitle': 'Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm', 'orgStudyIdInfo': {'id': 'N12HYB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation', 'description': 'combined CFRT and SABR with concurrent cisplatin', 'interventionNames': ['Radiation: SABR', 'Drug: Cisplatin']}], 'interventions': [{'name': 'SABR', 'type': 'RADIATION', 'description': 'combined CFRT and SABR with concurrent cisplatin', 'armGroupLabels': ['Radiation']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'combined CFRT and SABR with concurrent cisplatin', 'armGroupLabels': ['Radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Heike Peulen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}