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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 79
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Chest Hospital
RECRUITING
Hefei
The First Affiliated Hospital of University of Science and Technology of China
RECRUITING
Hefei
Huzhou Central Hospital
RECRUITING
Huzhou
Shandong Public Health Clinical Center
RECRUITING
Jinan
Affiliated Hospital of Nantong University
RECRUITING
Nantong
The Sixth People's Hospital of Nantong
RECRUITING
Nantong
Nanyang Central Hospital
RECRUITING
Nanyang
Ningbo First Hospital
RECRUITING
Ningbo
Ningbo No.2 Hospital
RECRUITING
Ningbo
Huadong Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Yancheng First People's Hospital
RECRUITING
Yancheng
Contact Information
Primary
Hang Su
dreamsuhang@163.com
+86 13917810850
Backup
Chang Chen, MD, PhD
chenthoracic@163.com
+86 021-65115006
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 690
Treatments
Experimental: Segmentectomy with systemic lymph node dissection
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.
Active_comparator: Lobectomy with systemic lymph node dissection
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pulmonary Hospital, Shanghai, China

This content was sourced from clinicaltrials.gov