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A Multi-center Prospective Clinical Trial Exploring Surgical Strategies For Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial On Surgical Strategies For Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062165
Enrollment
Unknown
Registered
2022-07-26
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Group A:Wedge resection
Group B:Segmentectomy

Sponsors

National Cancer Center/National Clinical Research Center for Cancer/Department of Thoracic Surgery,Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Chin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Chest computed tomography (CT) meets all of the following conditions: (a) Single tumor or multiple tumors, but other tumors other than the main lesion are expected to require no surgical intervention within 1 year; (b) Imaging is considered NSCLC; (c) The tumor center is located in the outer third of the lung field. 2.The tumor characteristics of thin-section CT also meet the following conditions: (a) The largest tumor diameter is less than or equal to 2 cm; (b) 0.25=the ratio of the largest diameter of the solid component of the tumor to its own largest diameter <1. 3.Patients aged 20–75 years. 4.No history of thoracic lung surgery (previous diagnostic thoracoscopy or mediastinal tumor resection are allowed). 5.Preoperative FEV1.0=1.5L. 6.ECOG grading of 0 or 1. 7.Sign the written informed consent. 8.The function of each organ can tolerate surgery. 9.Preoperative body temperature=38?. 10.Receive surgery within 30 days of initial registration. 11.Histologically confirmed adenocarcinoma, squamous cell carcinoma or other types of non-small cell lung cancer (detailed category unknown). 12.No malignant pleural effusion or pleural dissemination. 13.Wedge resection, segmentectomy and lymph node dissection are technically possible.

Exclusion criteria

Exclusion criteria: 1.Lymph node metastases are considered with radiologically evident; 2.Excision of the superior lobe or basal segment of left lung; 3.Active bacterial or fungal infection in lung; 4.History of other malignant tumors (excluding clinically cured malignant tumors, such as papillary thyroid carcinoma, breast cancer, clear cell renal carcinoma, etc.) 5.Pregnant or lactating women; 6.With interstitial pneumonia, pulmonary fibrosis or severe emphysema; 7.With mental disease; 8.Taking systemic steroid drugs; 9.With uncontrolled diabetes; 10.With uncontrolled hypertension; 11.History of severe heart disease, heart failure, myocardial infarction, or angina pectoris in the past 6 months. 12.Benign lesions were confirmed intraoperative or postoperative (including precancerous lesions: adenomatous hyperplasia). 13.Intraoperative exploration revealed obvious pleural invasion, pleural dissemination, malignant pleural effusion, and other situations that were not suitable for wedge resection or segmentectomy. 14.The minimum distance between the tumor edge and the staple incision edge is less than 2 cm, or less than the maximum diameter of the tumor. 15.No frozen pathological examination of N1 lymph node was performed during the operation, or cancer metastasis was found. 16.After being selected, the patients with severe preoperative complications (inability to tolerate surgery or anesthesia) are not suitable or unable to implement the treatment plan. 17.After the selection, the doctor in charge confirms that it is necessary to switch from elective surgery to emergency surgery due to the changes of patient's condition. 18.The patient voluntarily requests to withdraw or discontinue the treatment due to the patient's personal reasons at any stage after entering the study. 19.Implement treatment that violates the research protocol. 20.Those who have not undergone surgery within 30 days (including 30 days) after randomization.

Design outcomes

Primary

MeasureTime frame
Overall survival;Disease free survival;

Countries

China

Contacts

Public ContactShugeng Gao

Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Chin

gaoshugeng@cicams.ac.cn13801185056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026