Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT01647334
Status:
TERMINATED
Last Update Posted:
2015-02-19
First Post:
2012-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-17', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor reduction', 'timeFrame': '2.5 years (end of treatment)'}], 'secondaryOutcomes': [{'measure': 'Rate of tumor shrinkage', 'timeFrame': '2.5 years (end of treatment)'}, {'measure': 'Change in lung dose', 'timeFrame': '2.5 years (end of treatment)'}, {'measure': 'Delivered doses', 'timeFrame': '2.5 years (end of treatment)'}, {'measure': 'Radiation pneumonitis rates', 'timeFrame': '6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)'}, {'measure': 'Local control', 'timeFrame': '2.5 years (end of treatment)'}, {'measure': 'Overall survival', 'timeFrame': '2.5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Willing to provide informed consent\n* ECOG performance status 0-2\n* Histologically confirmed non-small cell lung carcinoma\n* Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition\n* Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation\n* Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist\n\nExclusion Criteria:\n\n* Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy\n* Prior history of lung cancer within 5 years\n* Prior thoracic radiation at any time\n* Metastatic disease\n* in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.\n* inability to attend full course of radiotherapy of follow-up visits\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01647334', 'briefTitle': 'Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'Lung-START'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shrinking Target Adaptive Radiotherapy', 'description': 'Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer', 'interventionNames': ['Radiation: Adaptive radiotherapy']}], 'interventions': [{'name': 'Adaptive radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Shrinking Target Adaptive Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program of the Lawson Health Research Institute', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'David Palma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Regional Cancer Program of the Lawson Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'London Regional Cancer Program, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Palma', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}