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A multi-center, prospective, randomized controlled clinical trial for comparison between wedge resection and segmentectomy in the surgical treatment of ground glass opacity-dominant early stage non-small cell lung cancer

A multi-center, prospective, randomized controlled clinical trial for comparison between wedge resection and segmentectomy in the surgical treatment of ground glass opacity-dominant early stage non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019666
Enrollment
Unknown
Registered
2018-11-21
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-26

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

Conditions

Non-Small Cell Lung Cancer

Interventions

Group 1:Wedge resection
Group 2:Segmentectomy

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions: Lesion size is more than 5 mm but equal to or less than 20 mm; Ground glass opacity/tumor (C/T) ratio is equal to or more than 75%; 3. Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging); 4. The center of the tumor is located in the outer third of the lung field; 5. R0 resectable in segmentectomy and wedge resections plus hilar/mediastinal lymph node resection; 6. Preoperative FEV1.0>=1.0 L and >= 50% of the expected value; 7. Performance status of ECOG 0 or 1; 8. Preoperative ASA scoring (American society of anesthesiology) class I -III; 9. The patient agrees to participate in the trial and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Quit smoking <2 weeks; 2. Multiple ground glass nodules with suspect of multiple primary lung cancer; 3. TSCT shows that the lesion is located in the right middle lobe; 4. The lesion is located between two segments with possibility of combined segmental resection; 5. Pregnant or lactating women; 6. Serious mental illness; 7. With other malignant disease history within 5 years; 8. With the history of unstable angina or myocardial infarction within 6 months; 9. With the history of cerebral infarction or cerebral hemorrhage within 6 months; 10. With the history of sustained systemic corticosteroid therapy within 1 month; 11. Other unsuitable situations.

Design outcomes

Primary

MeasureTime frame
5-year Disease-Free Survival;

Secondary

MeasureTime frame
3-year Disease Free Survival;5-year Overall Survival;10-year Overall Survival;30-day Morbidity and mortality;Pulmonary function in the first year;

Countries

China

Contacts

Public ContactQingquan Luo/Yunhai Yang

Shanghai Chest Hospital

luoqingquan@hotmail.com+86 13003247676

Outcome results

None listed

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