Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT06102161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year overall survival', 'timeFrame': '5 years', 'description': 'The event is defined as the death due to any causes.'}], 'secondaryOutcomes': [{'measure': '5-year recurrence-free survival', 'timeFrame': '5 years', 'description': 'The event is defined as the tumor recurrence.'}, {'measure': 'Postoperative lung function (FEV1)', 'timeFrame': '5 years', 'description': 'forced expiratory volume in one second (FEV1)'}, {'measure': 'Postoperative lung function', 'timeFrame': '5 years', 'description': 'forced vital capacity (FVC)'}, {'measure': 'Sites of tumor recurrence and metastasis', 'timeFrame': '5 years'}, {'measure': 'Radical wedge resection (R0 resection) completion rate', 'timeFrame': '5 years'}, {'measure': 'Surgery-related complications', 'timeFrame': '5 years'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Wedge Resection', 'Ground-glass Opacity']}, 'referencesModule': {'references': [{'pmid': '39144343', 'type': 'DERIVED', 'citation': 'Li T, Fu F, Zhang Y, Chen H. Protocol for a single-arm, multicenter, prospective, confirmatory phase III trial of wedge resection for invasive ground glass opacity-featured lung cancer with a size </=2 cm and a consolidation tumor ratio between 0.25 and 0.5 (ECTOP-1020 study). J Thorac Dis. 2024 Jul 30;16(7):4711-4718. doi: 10.21037/jtd-24-440. Epub 2024 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who sign the informed consent form and are willing to complete the study according to the plan;\n2. Aged from 18 to 80 years old;\n3. ECOG equals 0 or 1;\n4. Not receiving lung cancer surgery before;\n5. Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;\n6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;\n7. The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm;\n8. peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.\n9. cT1N0M0 tumors;\n10. Complete tumor resection by wedge resection as assessed by the surgeon;\n11. Not receiving chemotherapy or radiotherapy before.\n\nExclusion Criteria:\n\n1. Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.\n2. CTR is not between 0.25-0.5 or nodule size greater than 2 cm;\n3. Cannot be completely resected by wedge resection;\n4. Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;\n5. Receiving lung cancer surgery before;\n6. Receiving radiotherapy or chemotherapy.'}, 'identificationModule': {'nctId': 'NCT06102161', 'briefTitle': 'Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial', 'orgStudyIdInfo': {'id': 'WGGO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wedge resection', 'description': 'Wedge resection is performed for early-stage lung cancer to remove a wedge-shaped section of lung tissue.', 'interventionNames': ['Procedure: Wedge resection']}], 'interventions': [{'name': 'Wedge resection', 'type': 'PROCEDURE', 'description': 'Wedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer.', 'armGroupLabels': ['Wedge resection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tong Li', 'role': 'CONTACT', 'email': 'litong_medical@163.com', 'phone': '+86 18813039287'}]}, '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'}}}}