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 range
20 Years – 79 Years
Sex
ALL
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:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
recurrence-free survival rate
Timeframe: 5 year
Trial details
NCT IDNCT04937283
SponsorShanghai Pulmonary Hospital, Shanghai, China