NCT04937283 Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
| NCT ID | NCT04937283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 690 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 690 participants in total. It began in 2019-10-01 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Chang Chen, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Frequently Asked Questions
Who can join the NCT04937283 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 79 Years, studying Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04937283 currently recruiting?
Yes, NCT04937283 is actively recruiting participants. Contact the research team at dreamsuhang@163.com for enrollment information.
Where is the NCT04937283 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Nanyang, China, Nantong, China and 10 additional locations.
Who is sponsoring the NCT04937283 clinical trial?
NCT04937283 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The principal investigator is Chang Chen, MD, PhD at Shanghai Pulmonary Hospital, School of Medicine, Tongji University. The trial plans to enroll 690 participants.