Protocol for a single-arm, multicenter, prospective, confirmatory phase III trial of wedge resection for invasive ground glass opacity-featured lung cancer with a size ≤2 cm and a consolidation tumor ratio between 0.25 and 0.5 (ECTOP-1020 study).

BACKGROUND

Segmentectomy is the current standard treatment for ground glass opacity (GGO)-featured lung cancer patients with a tumor size ≤2 cm and a consolidation tumor ratio (CTR) between 0.25 and 0.5. However, compared with wedge resection, segmentectomy destroys the patient's hilar structure and consumes more lung parenchyma. A recent study demonstrated that wedge resection could yield comparable results for this group of patients.

METHODS

This study aimed to confirm the noninferiority of wedge resection over standard surgery in invasive GGO-featured lung cancer patients with a size ≤2 cm and a CTR between 0.25 and 0.5, as measured by 5-year overall survival (OS). The primary endpoint is 5-year OS. The secondary endpoints are 5-year recurrence-free survival (RFS), the R0 resection rate, pulmonary function, recurrence and metastasis sites, and adverse events after surgery. During the trial period, 286 patients are enrolled from six Chinese institutions.

DISCUSSION

The primary results of this study will be actively disseminated through manuscript publications and conference presentations. This prospective study will evaluate the surgical efficacy and safety of wedge resection for small (tumor size ≤2 cm with a CTR between 0.25 and 0.5) invasive GGO-featured lung cancer and will support the standardization of this surgical strategy.

TRIAL REGISTRATION

This trial has been registered on ClinicalTrial.gov (No. NCT06102161).