Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-25 @ 5:40 PM
Study NCT ID:
NCT00346320
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2006-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002282', 'term': 'Adenocarcinoma, Bronchiolo-Alveolar'}], 'ancestors': [{'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2014-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2006-06-28', 'studyFirstSubmitQcDate': '2006-06-28', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor control rate at 2 years', 'timeFrame': '2 years', 'description': 'Overall tumor control rate will be assessed at 6 years'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '6 years'}, {'measure': 'Disease recurrence rates', 'timeFrame': '6 years'}, {'measure': 'Progression-free survival', 'timeFrame': '6 years'}, {'measure': 'Overall survival', 'timeFrame': '6 years'}, {'measure': 'Quality of life', 'timeFrame': '6 years'}, {'measure': 'Changes in pulmonary function', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'bronchoalveolar cell lung cancer', 'large cell lung cancer', 'squamous cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25074417', 'type': 'RESULT', 'citation': "Cheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.\n\nPURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.\n\nSecondary\n\n* Determine the toxicities of this regimen in these patients.\n* Determine the rates of regional and distant disease recurrence in these patients.\n* Determine the progression-free and overall survival of patients treated with this regimen.\n* Determine the changes in pulmonary function after treatment in these patients.\n* Assess the quality of life of patients after treatment.\n\nOUTLINE: This is a multicenter, prospective study.\n\nPatients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.\n\nAfter completion of study treatment, patients are followed periodically for 5 years.\n\nPROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)\n\n * Stage I or II peripheral disease\n\n * T1, N0, M0\n * T2 (≤ 5 cm), N0, M0\n * T3 (≤ 5 cm, chest wall primary tumor only), N0, M0\n * No T2-T3 primary tumors \\> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement\n * No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)\n * Hilar or mediastinal lymph nodes ≤ 1 cm considered N0\n * Any of the following primary cancer types:\n\n * Squamous cell carcinoma\n * Adenocarcinoma\n * Large cell carcinoma\n * Bronchioloalveolar cell carcinoma\n * Non-small cell carcinoma not otherwise specified\n* Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)\n* Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed\n\n * If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen\n* Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs\n* No ataxia telangiectasia\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Not pregnant or nursing\n* Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)\n* No active systemic, pulmonary, or pericardial infection\n* No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.\n\n * Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior radiotherapy to the area of the primary tumor\n* No prior or concurrent chemotherapy or immunotherapy for this tumor'}, 'identificationModule': {'nctId': 'NCT00346320', 'briefTitle': 'Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'BR25'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-BR25', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000486919', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': '3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks', 'interventionNames': ['Radiation: 3-dimensional conformal radiation therapy']}], 'interventions': [{'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'description': '3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks', 'armGroupLabels': ['Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Cancer Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Fraser Valley Cancer Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 6V5', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Atlantic Health Sciences Corporation', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'AIB 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Dr. H. Bliss Murphy Cancer Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre at Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Centre of Southeastern Ontario at Kingston', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lakeridge Health Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Science Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Hopital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University - Dept. Oncology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUQ-Pavillon Hotel-Dieu de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Patrick CF Cheung, MD, FRCPC', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto Sunnybrook Regional Cancer Centre'}, {'name': 'Sergio L Faria, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Montreal General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}