Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chest Hospital
About this trial
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 \<=2 cm. Eligible participants will undergo centralized imaging review and will be randomized preoperatively in a 1:1 ratio before induction of anesthesia.
The primary endpoint is 5-year overall survival. The key supportive secondary endpoint is 5-year recurrence-free survival. The study will enroll 1,200 participants and will use intention-to-treat analysis for the primary endpoint. An independent Data and Safety Monitoring Board and an independent Endpoint Adjudication Committee will oversee safety, surgical quality, data quality, and endpoint adjudication.
Eligibility criteria
Qualifiers
Age 18 to 80 years.
Solitary pulmonary nodule with maximum diameter <=2 cm confirmed by preoperative thin-slice CT (<=1 mm) and 3D reconstruction.
Solid-dominant nodule with consolidation-to-tumor ratio (CTR) >0.5, including pure-solid nodules.
Deeply located lesion, defined as the lesion center located in the inner two-thirds of the lung field on axial, coronal, and sagittal MPR images.
Disqualifiers
Lesion located in the right middle lobe.
Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
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.
Prior ipsilateral lung surgery or another malignancy within 5 years.
Trial design
Treatments tested in this trial
- Anatomic Segmentectomy
- Anatomic Lobectomy
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov