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Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

RECRUITINGN/ASponsored by Shanghai Pulmonary Hospital, Shanghai, China
Actively Recruiting
PhaseN/A
SponsorShanghai Pulmonary Hospital, Shanghai, China
Started2019-10-01
Est. completion2028-12-30
Eligibility
Age20 Years – 79 Years
Healthy vol.Accepted

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.

Eligibility

Age: 20 Years – 79 YearsHealthy volunteers accepted
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 the normal upper limit);
* Patients with other malignant tumors;
* Pregnant, planned pregnancy and lactating female patients (urine HCG\>2500IU/L is diagnosed as early pregnancy);
* Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
* Those who have participated in other tumor-related clinical trials within three months;
* Those are not suitable for participating in trials according to investigator's assessment.

Conditions3

CancerLung AdenocarcinomaLung Cancer

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