The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
Patients randomized to the investigational group will undergo an anatomical lobectomy. Subsequently, no further lymph node resection or dissection will be performed in regional stations confirmed negative for metastasis by preoperative or intraoperative pathological evaluation (including negative preoperative endobronchial ultrasound \[EBUS\]-guided biopsies and negative intraoperative frozen sections). Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
Patients randomized to the control group will undergo a systematic mediastinal lymph node dissection following the completion of an anatomical lobectomy. A radical dissection and clearance of the mediastinal lymph nodes will be performed. For right-sided procedures, this encompasses the right upper paratracheal, right lower paratracheal, and subcarinal regions; for left-sided procedures, this encompasses the para-aortic, aortopulmonary window, left lower paratracheal, and subcarinal regions. Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
2-year event-free survival (EFS) rate
Time frame: Up to 2 years
2-year disease-free survival (DFS) rate
Time frame: Up to 2 years
2-year overall survival (OS) rate
Time frame: Up to 2 years
Dynamic changes in absolute and relative peripheral blood lymphocyte counts
Time frame: Up to 2 years
Length of hospital stay
Time frame: Up to 30 days post-operation
time of operation
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
postoperative recurrence rate (including the incidence of local recurrence and distant metastasis).
Time frame: Up to 2 years
Quality of life (QoL) scores at 6, 12, and 36 months postoperatively (assessed via the EORTC QLQ-C30).
Scale Title: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Minimum and Maximum Values: 0 to 5. Score Interpretation: The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. For the global health status and functional scales, higher scores represent a better quality of life/higher level of functioning. For the symptom scales, higher scores represent a higher level of symptomatology/worse outcome.
Time frame: 6, 12, and 24 months post-operation
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