Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA β¦ (NCT02718365) | Clinical Trial Compass
UnknownNot Applicable
Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC
China1,382 participantsStarted 2017-12-07
Plain-language summary
The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component β€ 75%, due to the high recurrence rate. When radiology shows that the GGO component is β₯75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size β€ 2 cm and GGO component β₯ 75%.
Who can participate
Age range18 Years β 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:
β. Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
β. R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
β. Aged 18 to 75 years old.
β. No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
β. Preoperative FEV1.0\>=1.0 L.
β. Performance status of ECOG 0 or 1.
β. Preoperative ASA scoring (American society of anesthesiology) class I -III.
Exclusion criteria
β. Quit smoking \<2 weeks.
β. Preoperative FEV1 \< 50% of the expected value.
What they're measuring
1
5-year Progression-Free-Survival
Timeframe: From date of the recruitment, assessed up to 60 months