Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
Sponsor
Fujian Medical University Union Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05983835
Collaborator
Wu Jieping Medical Foundation (Other)
688
1
2
36
19.1
Study Details
Study Description
Brief Summary
This project intends to include stage IA lung adenocarcinoma patients with CT imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
688 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
Actual Study Start Date
:
Oct 1, 2022
Anticipated Primary Completion Date
:
Oct 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: combined segmentectomy
|
Procedure: Patients receive subsegmentectomy
Patients receive lobectomy
|
| Placebo Comparator: lobectomy
|
Procedure: Patients receive subsegmentectomy
Patients receive lobectomy
|
Outcome Measures
Primary Outcome Measures
- Disease-Free Survival [2 years]
This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) , Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) PS score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy.
(7) FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant metastasis were found in the preoperative clinical evaluation, (9) voluntary participation and informed consent were obtained;
Exclusion Criteria:
- (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple GGO considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Medical University Union Hospital | Fuzhou | China | 350001 |
Sponsors and Collaborators
- Fujian Medical University Union Hospital
- Wu Jieping Medical Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier:
NCT05983835
Other Study ID Numbers:
- Union-01
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: