Clinical trial · Interventional
Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm
Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study
NCT04937283CI-TRIAL-00107860recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lobectomy | Procedure | — | UNRESOLVED |
| Segmentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Segmentectomy
- description
- Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.
- interventionNames
- Procedure: Segmentectomy
- type
- ACTIVE_COMPARATOR
- label
- Lobectomy
- description
- lobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intraoperatively. If the distance is either less than the maximum tumor diameter or ,20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.