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NCT07698990
Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
Conditions: Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1200
Sponsor: Shanghai Chest Hospital
Location: Shanghai Chest Hospital Shanghai Shanghai Municipality
Summary
SOLID is a multicenter, open-label, randomized, controlled, phase III non-inferiority trial comparing anatomic segmentectomy with lobectomy in patients with deeply located, solid-dominant, clinical stage IA non-small cell lung cancer (NSCLC) measuring \
Eligibility Criteria
Inclusion Criteria:
1. Age 18 to 80 years.
2. Solitary pulmonary nodule with whole-tumor maximal diameter \=95%. Preoperative pathologic confirmation is not mandatory, but preoperative or intraoperative pathology should be obtained when technically safe and feasible.
6. Complete staging with thin-slice contrast-enhanced chest CT, whole-body PET-CT, brain contrast-enhanced MRI or CT, and serum tumor markers as appropriate; clinical stage IA (cT1a-bN0M0) without regional nodal or distant metastasis.
7. Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO \>=60% predicted.
8. Written informed consent, including special disclosure that final pathology may be benign.
9. Centralized imaging review confirmation by the lead-center technical committee before randomization.
Exclusion Criteria:
1. Lesion located in the right middle lobe.
2. Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
3. Two or more lesions requiring anatomic resection. One secondary lesion requiring only non-anatomic wedge resection is allowed; two main lesions in the same segment are excluded.
4. Prior ipsilateral lung surgery or another malignancy within 5 years.
5. Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
6. Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
Source: ClinicalTrials.gov (NCT07698990). StuddyBuddy aggregates publicly available trial information.