Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC (SOLID)
Comparison of Segmentectomy and Lobectomy for Deeply Located, Solid-Dominant Early-Stage Non-Small Cell Lung Cancer (<=2 cm): A Multicenter, Open-Label, Randomized, Controlled, Non-Inferiority Clinical 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Segmentectomy has been established as an accepted treatment option for selected small peripheral NSCLC, but high-level randomized evidence is limited for tumors located in the inner two-thirds of the lung parenchyma. Deep, solid-dominant nodules may have higher oncologic risk, more complex anatomy, and greater difficulty achieving conventional linear surgical margins.
This trial evaluates whether standardized anatomic segmentectomy, including surgical quality control and lymph-node dissection requirements, is non-inferior to lobectomy for overall survival in patients with deeply located, solid-dominant, clinical stage IA NSCLC <=2 cm. The trial incorporates centralized pre-randomization imaging review, mandatory recording of margin and surgical quality metrics, systematic or lobe-specific lymph-node dissection, independent endpoint adjudication, and DSMB safety and quality oversight.
Participants randomized to the segmentectomy arm will undergo anatomic segmentectomy when feasible. Conversion to lobectomy is required for intraoperative frozen-section N1/N2 nodal metastasis and may occur for inadequate margins, anatomic difficulty, or safety concerns. Participants randomized to the lobectomy arm will undergo standard anatomic lobectomy. Intraoperative findings and final pathology do not change the original randomized assignment for the primary intention-to-treat analysis.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Chest Hospital
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Contacto:
- Qing Shanghai Chest Hospital
- Número de teléfono: 18516349006
- Correo electrónico: pillawang@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
- Clinically definite suspected primary NSCLC after complete preoperative work-up and MDT discussion, with estimated malignancy probability >=95%. Preoperative pathologic confirmation is not mandatory, but preoperative or intraoperative pathology should be obtained when technically safe and feasible.
- 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.
- Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO >=60% predicted.
- Written informed consent, including special disclosure that final pathology may be benign.
- Centralized imaging review confirmation by the lead-center technical committee before randomization.
Exclusion Criteria:
- 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.
- Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
- Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Segmentectomy
Participants assigned to this arm will undergo anatomic pulmonary segmentectomy.
Combined segmentectomy or proper segmentectomy is permitted; basal segmentectomy (S7-10) is prohibited.
Segmentectomy must include anatomic treatment of the segmental hilar artery, vein, and bronchus, margin assessment, and required lymph-node dissection.
Conversion to lobectomy is permitted or required according to protocol-defined clinical and safety criteria.
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Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
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Comparador activo: Lobectomy
Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
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Anatomical resection of the involved pulmonary lobe with lymph-node dissection.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival
Periodo de tiempo: 5 years after randomization
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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.
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5 years after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence-Free Survival
Periodo de tiempo: 5 years after randomization
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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.
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5 years after randomization
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Locoregional Recurrence Rate
Periodo de tiempo: Up to 5 years after randomization
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Proportion of participants with recurrence at the surgical margin, ipsilateral remaining lung, or ipsilateral hilar/mediastinal lymph nodes.
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Up to 5 years after randomization
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Distant Metastasis Rate
Periodo de tiempo: Up to 5 years after randomization
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Proportion of participants with metastasis involving contralateral lung, pleura, N3 lymph nodes, or extrathoracic organs.
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Up to 5 years after randomization
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Patient-Reported Quality of Life Score (EORTC QLQ-C30)
Periodo de tiempo: Baseline and 6, 12, and 36 months after surgery
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Patient-reported quality of life measured using EORTC QLQ-C30, with attention to dyspnea, chest pain, and cough.
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Baseline and 6, 12, and 36 months after surgery
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Six-Minute Walk Distance
Periodo de tiempo: Baseline and 6 and 12 months after surgery
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Change in 6-minute walk test distance.
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Baseline and 6 and 12 months after surgery
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FEV1 Change Rate
Periodo de tiempo: Baseline and 6 and 12 months after surgery
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Change or loss rate in FEV1 (Forced Expiratory Volume in 1 second).
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Baseline and 6 and 12 months after surgery
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Surgical Quality Metrics
Periodo de tiempo: Perioperative period
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Surgical grade distribution, margin distance, R0 resection rate, lymph-node dissection station and count compliance, and conversion rate from segmentectomy to lobectomy.
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Perioperative period
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Perioperative Complications
Periodo de tiempo: Through discharge or 30 days after surgery, whichever came first
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Postoperative adverse events graded by Clavien-Dindo, with emphasis on grade II or higher complications.
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Through discharge or 30 days after surgery, whichever came first
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30-Day Mortality
Periodo de tiempo: 30 days after surgery
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All-cause mortality within 30 days after surgery.
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30 days after surgery
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DLCO Change Rate
Periodo de tiempo: Baseline and 6 and 12 months after surgery
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Change or loss rate in DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide).
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Baseline and 6 and 12 months after surgery
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Patient-Reported Lung Cancer Symptom Score (EORTC QLQ-LC13)
Periodo de tiempo: Baseline and 3, 6, 12, and 36 months after surgery
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Patient-reported lung cancer-specific symptoms measured using EORTC QLQ-LC13, with attention to dyspnea, chest pain, and cough.
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Baseline and 3, 6, 12, and 36 months after surgery
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90-Day Mortality
Periodo de tiempo: 90 days after surgery
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All-cause mortality within 90 days after surgery.
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90 days after surgery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SOLID-V1.9
Información sobre medicamentos y dispositivos, documentos del estudio
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