Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT05183932
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery Versus Stereotactic Body Radiation Therapy for Stage I 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 444}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Through 36 months post-treatment (estimated to be 36 months and 1 week)', 'description': 'DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier.'}, {'measure': 'Change in patient-reported outcomes as measured by the PROMIS Bank survey', 'timeFrame': 'From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)', 'description': '* Surveys will occur at baseline, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment\n* The PROMIS scores will be compared across the 8 pre-specified domains:\n\n * Cancer Bank v1.1 - Physical Function\n * Cancer Bank v1.1 - Pain Interference\n * Cancer Bank v1.0 - Fatigue\n * Cancer Bank v1.0 - Depression\n * Cancer Bank v1.0 - Anxiety\n * Bank v1.0 - Dyspnea Severity\n * Bank v2.0 - Ability to Participate in Social Roles and Activities\n * Bank v2.0 - Cognitive Function\n* PROMIS is scored 1-100 and normalizes to the population mean of 50 with each 10 being a standard deviation. A higher score indicates a worse patient-reported outcome.'}], 'secondaryOutcomes': [{'measure': 'Cancer-specific survival (CSS)', 'timeFrame': 'Through 36 months post-treatment (estimated to be 36 months and 1 week)', 'description': 'Cancer-specific survival (CSS) is defined as time from the date of treatment to date of cancer-related death. The alive patients without any signs or symptoms of that cancer are censored at the last follow-up.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through 36 months post-treatment (estimated to be 36 months and 1 week)', 'description': 'Overall survival (OS) is defined as time from the date of treatment to date of death. The alive patients are censored at the last follow-up.'}, {'measure': 'Treated-related mortality', 'timeFrame': 'At 30 days (estimated to be 1 month and 1 week)'}, {'measure': 'Number of post-treatment events (grade 3 and above)', 'timeFrame': 'Through 36 months post-treatment (estimated to be 36 months and 1 week)', 'description': 'Post-treatment grade 3-5 events measured via CTCAE version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer', 'Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who meet the eligibility criteria from any of the participating sites listed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical stage I NSCLC (T1 or T2a, N0, M0) by CT performed within 90 days of screening.\n\n * PET/CT is required within 90 days of screening except under circumstances where the clinical picture suggests, or biopsy confirms, a low-grade adenocarcinoma.\n * Biopsy is strongly encouraged. In the event biopsy is not performed, rationale must be provided for performing empiric treatment.\n * Patients with hilar or mediastinal lymph nodes ≤ 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Pre-treatment mediastinal lymph node sampling by any technique is allowed but not required. Patients with \\> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) are be eligible only if directed tissue biopsies of all abnormally identified areas are negative for cancer.\n* First primary NSCLC on the ipsilateral side.\n* At least 18 years of age.\n* Clinically eligible for either treatment (surgical resection or SBRT). Because this is a pragmatic study and treatment decisions are at the discretion of the treating physicians and their patients, patients must be eligible for either treatment. To be considered eligible for either treatment, patients must have:\n\n * ECOG performance status ≤ 2\n * No home oxygen use\n * FEV1 and DLCO ≥ 40% predicted\n * No symptomatic congestive heart failure as documented by NYHA I-II functional classification\n * Been deemed operable by a thoracic surgeon, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to operability, the surgeon must define what anticipated surgical approach and procedure would be undertaken.\n * Been deemed treatable by a radiation oncologist with 10 or fewer fractions of SBRT, per clinical visit or review of the medical record and as documented by e-mail, tumor board, study meetings, or other acceptable source documentation. In addition to suitability for SBRT, the radiation oncologist must define which dose and fractionation would be undertaken.\n* Ability to understand and willingness to sign an IRB-approved written informed consent document.\n* Agrees to receive treatment for clinical stage I NSCLC (either surgical resection or SBRT).\n\nExclusion Criteria:\n\n* Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study.\n* Clinically diagnosed or biopsy proven low-grade neuroendocrine carcinoma (carcinoid).\n* Prior thoracic radiation therapy that would overlap with the lung cancer being treated on study.\n* Previous chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on study.\n* Prior lung resection on the ipsilateral side positive for malignancy.\n* Patients with central tumors requiring a sleeve lobectomy or pneumonectomy.\n* "Ultra-central" lesions (defined as a lesion that directly contacts or overlaps the trachea, main bronchus, esophagus, or pulmonary vessels).\n* Concurrent enrollment in a therapeutic trial for the index cancer.\n* Synchronous primary lung cancer.\n* Uncontrolled or symptomatic psychiatric condition.'}, 'identificationModule': {'nctId': 'NCT05183932', 'acronym': 'SORT', 'briefTitle': 'Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Comparing the Effectiveness of Surgery Versus Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer (SORT)', 'orgStudyIdInfo': {'id': '202112102'}, 'secondaryIdInfos': [{'id': 'R01CA258681', 'link': 'https://reporter.nih.gov/quickSearch/R01CA258681', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery', 'description': '* Participants will have standard of care lobectomy/segmentectomy/wedge resection. Decision for treatment will be made at the discretion of the treating physician.\n* PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment\n\n * Bank 2.0 - Physical Function\n * Bank v1.1 - Pain Interference\n * Bank v1.0 - Fatigue\n * Bank v1.0 - Depression\n * Bank v1.0 - Anxiety\n * Bank v1.0 - Dyspnea Severity\n * Bank v2.0 - Ability to Participate in Social Roles and Activities\n * Bank v2.0 - Cognitive Function'}, {'label': 'Stereotactic body radiotherapy (SBRT)', 'description': '* Participants will have standard of care 1-10 fractions of radiation therapy. Decision for treatment will be made at the discretion of the treating physician.\n* PROMIS instruments include 8 domains and will be completed prior to treatment, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment\n\n * Bank v2.0 - Physical Function\n * Bank v1.1 - Pain Interference\n * Bank v1.0 - Fatigue\n * Bank v1.0 - Depression\n * Bank v1.0 - Anxiety\n * Bank v1.0 - Dyspnea Severity\n * Bank v2.0 - Ability to Participate in Social Roles and Activities\n * Bank v2.0 - Cognitive Function'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sinisa Stanic, M.D.', 'role': 'CONTACT', 'phone': '217-383-3311'}, {'name': 'Sinisa Stanic, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carle Cancer Institute', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin D Kozower, M.D., MPH', 'role': 'CONTACT', 'email': 'kozowerb@wustl.edu', 'phone': '314-362-8089'}, {'name': 'Benjamin D Kozower, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Varun Puri, M.D., MSCI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cliff Robinson, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Esther Lu, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Margaret Olsen, Ph.D., MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Jones, M.D.', 'role': 'CONTACT', 'phone': '212-639-2000'}, {'name': 'David Jones, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Narek Shaverdian, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ara Vaporciyan, M.D.', 'role': 'CONTACT', 'phone': '877-284-1820'}, {'name': 'Ara Vaporciyan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joe Chang, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Benjamin D Kozower, M.D., MPH', 'role': 'CONTACT', 'email': 'kozowerb@wustl.edu', 'phone': '314-362-8089'}], 'overallOfficials': [{'name': 'Benjamin D Kozower, M.D., MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}