Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT07250360
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC
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': 'ACTUAL', 'count': 2072}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-28', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.', 'timeFrame': 'Up to 5 years after surgery', 'description': 'DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals.'}], 'secondaryOutcomes': [{'measure': '5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method', 'timeFrame': 'Up to 5 years after surgery.', 'description': 'RFS is defined as the time from surgery to the date of first documented tumor recurrence (local, regional, or distant) or death from any cause, whichever occurs first. Patients who are alive and recurrence-free will be censored at the date of last follow-up. Data will be analyzed using Kaplan-Meier survival estimates, with median RFS and 95% confidence intervals reported.'}]}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer Stage I']}, 'descriptionModule': {'briefSummary': 'Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.\n\nThe main questions it aims to answer are:\n\nDoes ACT improve recurrence-free survival (RFS) compared with observation alone?\n\nDoes ACT provide disease-free survival (DFS) benefit in this patient population?\n\nResearchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.\n\nParticipants will:\n\nReceive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.\n\nBe followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with non-squamous NSCLC from four participating hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have histologically confirmed non-squamous NSCLC\n2. Patients must be ≥18 years of age at the time of diagnosis\n3. Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)\n4. Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection\n5. Surgery performed between January 1, 2015 and December 31, 2019\n\nExclusion Criteria:\n\n1. Prior history of malignant tumors or presence of synchronous other primary malignancy\n2. Multiple primary lung cancers diagnosed at baseline\n3. Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy\n4. Perioperative death occurring within 30 days after surgery\n5. Incomplete or missing clinical or pathological information\n6. Loss to follow-up before the first scheduled surveillance assessment'}, 'identificationModule': {'nctId': 'NCT07250360', 'briefTitle': 'Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Adjuvant Chemotherapy Confers Survival Benefit Only in High-Risk Pathologic Stage I Non-Squamous NSCLC: A Multicenter Prospective Cohort Study and Machine-Learning-Based Decision Tool', 'orgStudyIdInfo': {'id': 'No. 2024-SR-1028'}, 'secondaryIdInfos': [{'id': 'No. 2024-SR-1028', 'type': 'OTHER', 'domain': 'Jiangsu Province Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adjuvant chemotherapy', 'interventionNames': ['Drug: Adjuvant chemotheapy']}, {'label': 'Postoperative Observation'}], 'interventions': [{'name': 'Adjuvant chemotheapy', 'type': 'DRUG', 'description': 'apply adjuvant chemotheapy', 'armGroupLabels': ['Adjuvant chemotherapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}