Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT05717803
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 307}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year disease-free survival', 'timeFrame': '5 years', 'description': 'The event is defined as the tumor recurrence or the death due to any causes.'}], 'secondaryOutcomes': [{'measure': 'Lung function test', 'timeFrame': 'Half year and one year after surgical resection', 'description': 'FEV1/FVC'}, {'measure': '5-year overall survival', 'timeFrame': '5 years', 'description': 'The event is defined as death due to any causes or last follow-up.'}, {'measure': 'The site of tumor recurrence and metastasis', 'timeFrame': 'From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.', 'description': 'Outpatient follow-up was conducted regularly after surgery, and the recurrence or metastasis site and time will be recorded.'}, {'measure': 'Segmentectomy completion rate', 'timeFrame': 'From the beginning of the surgery to the end of the surgery.', 'description': 'Proportion of patients who complete planned segmentectomy.'}, {'measure': 'Radical segmentectomy (R0 resection) completion rate', 'timeFrame': 'From surgery to the release of the final pathology report, an average of two weeks.', 'description': 'According to the postoperative pathology report of the patients, the proportion of patients with no residual tumor after radical segmentectomy accounted for all patients who underwent segmentectomy.'}, {'measure': 'Surgery-related complications', 'timeFrame': 'From surgery to patient discharge or 30 days after surgery.', 'description': 'such as air leak, atrial fibrillation, intraoperative or postoperative hemorrhage, postoperative infection, bronchopleural fistula, etc'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Segmentectomy', 'Lung Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '38960464', 'type': 'DERIVED', 'citation': 'Chen S, Huang Q, Fu F, Wang Z, Zhang Y, Chen H. Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2-3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012). BMJ Open. 2024 Jul 3;14(7):e087088. doi: 10.1136/bmjopen-2024-087088.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:\n\n* The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm;\n* The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who sign the informed consent form and are willing to complete the study according to the plan;\n* Aged from 18 to 80 years old;\n* ECOG equals 0 or 1;\n* Not receiving lung cancer surgery before;\n* Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;\n* Ground glass-dominant lung nodules\n* Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;\n* cN0 without distant metastasis;\n* Tumors could be completely resected assed by surgeons;\n* Not receiving chemotherapy or radiotherapy before.\n\nExclusion Criteria:\n\n* CTR is not 0-0.5, or size is not 2-3cm;\n* Tumors could not be completely resected assed by surgeons;\n* Not lung adenocarcinoma diagnosed cytologically or pathologically;\n* Receiving lung cancer surgery before;\n* Receiving radiotherapy or chemotherapy.'}, 'identificationModule': {'nctId': 'NCT05717803', 'briefTitle': 'Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial', 'orgStudyIdInfo': {'id': 'FUSCC2211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Segmentectomy', 'description': 'Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.', 'interventionNames': ['Procedure: Segmentectomy']}], 'interventions': [{'name': 'Segmentectomy', 'type': 'PROCEDURE', 'otherNames': ['Segment resection', 'Segment removal'], 'description': 'The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.', 'armGroupLabels': ['Segmentectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fangqiu Fu, M.D.', 'role': 'CONTACT'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Fangqiu Fu, M.D.', 'role': 'CONTACT', 'email': 'fufangqiu12@163.com', 'phone': '+86-13122677592'}], 'overallOfficials': [{'name': 'Haiquan Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director in the Department of Thoracic Surgery, FUSCC', 'investigatorFullName': 'Haiquan Chen', 'investigatorAffiliation': 'Fudan University'}}}}