Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm (NCT04937283) | Clinical Trial Compass
RecruitingNot Applicable
Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
China690 participantsStarted 2019-10-01
Plain-language summary
This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.
Who can participate
Age range20 Years – 79 Years
SexALL
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Inclusion Criteria:
* Patient aged 20-79 years old, both male or female;
* Tumor size \<= 2cm on preoperative CT scan;
* Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
* Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio \>= 0.25);
* Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (\<= 5%);
* Intraoperative frozen section indicated the resection margins was free of tumor cells;
* Lung function could withstand both lung segmentectomy and lobectomy (FEV1 \> 1.5L or FEV1% \>= 60%);
* Eastern Cooperative Oncology Group, 0 to 2;
* Volunteer to participate the trial and sign the informed consent, able to comply with the follow-up plan and other program requirements.
Exclusion Criteria:
* Radiological pure ground glass nodules (consolidation to tumor ratio \< 0.25);
* The nodule is close to the lung hilus and is unable to perform segmentectomy;
* Intraoperative frozen section confirmed with micropapillary and solid subtype positive (\> 5%);
* Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
* Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
* Preoperative imaging examination revealed distant metastasis;
* Patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, ALT and/or AST over 3 times the normal upper limit, Cr over …
What they're measuring
1
recurrence-free survival rate
Timeframe: 5 year
Trial details
NCT IDNCT04937283
SponsorShanghai Pulmonary Hospital, Shanghai, China