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
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years.
Solitary pulmonary nodule with whole-tumor maximal 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
Design model
Parallel
Treatments tested in this trial
Anatomic Segmentectomy
Procedure/SurgeryAnatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
Anatomic Lobectomy
Procedure/SurgeryAnatomical resection of the involved pulmonary lobe with lymph-node dissection.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: SegmentectomyExperimental treatment 1 intervention
Group B: LobectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. The primary analysis will compare segmentectomy with lobectomy using the intention-to-treat set and a non-inferiority hazard-ratio margin of 1.54.
Time frame
5 years after randomizationSecondary outcomes
1
Recurrence-Free Survival
Recurrence-free survival is defined as the time from randomization to first recurrence, distant metastasis, second primary lung cancer, or death from any cause. Event-free participants will be censored at the last event-free follow-up. RFS will be formally tested only if OS non-inferiority is established.
Time frame
5 years after randomization2
Locoregional Recurrence Rate
Proportion of participants with recurrence at the surgical margin, ipsilateral remaining lung, or ipsilateral hilar/mediastinal lymph nodes.
Time frame
Up to 5 years after randomization3
Distant Metastasis Rate
Proportion of participants with metastasis involving contralateral lung, pleura, N3 lymph nodes, or extrathoracic organs.
Time frame
Up to 5 years after randomization4
Patient-Reported Quality of Life Score (EORTC QLQ-C30)
Patient-reported quality of life measured using EORTC QLQ-C30, with attention to dyspnea, chest pain, and cough.
Time frame
Baseline and 6, 12, and 36 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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