Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
1 other identifier
observational
630
1 country
1
Brief Summary
The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 11, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedNovember 11, 2014
November 1, 2014
3.3 years
October 11, 2014
November 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death
Secondary Outcomes (2)
Overall survival
at least 5 years
Pulmonary function
Forced expiratory volume in one second, FEV1
Study Arms (2)
Arm I
Patients undergo lobectomy
Arm II
Patients undergo a wedge resection or anatomical segmentectomy
Eligibility Criteria
Patients are stratified according to age and lesion type (GGO component ratio) two matching factor of 1: 2 to the lobectomy and sub-lobectomy surgery groups.
You may qualify if:
- clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
- T≤2cm，N0，M0.
- aged 60 to 80 years old.
- ECOG≤2.
- according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
- voluntary participation, signed informed consent.
You may not qualify if:
- pathologic stage is N1, N2, or M1a.
- received postoperative adjuvant therapy (chemotherapy or targeted therapy).
- radiotherapy or chemotherapy before surgery.
- small cell lung cancer
- benign lesions
- patient unwilling to cooperate with surgery or observation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capital Medical Universitylead
- Beijing Chao Yang Hospitalcollaborator
- Beijing Friendship Hospitalcollaborator
- Beijing Chest Hospitalcollaborator
- Beijing Tongren Hospitalcollaborator
- Peking University First Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
- Beijing Anzhen Hospitalcollaborator
- Peking University Cancer Hospital & Institutecollaborator
Study Sites (1)
Xuanwu hospital capital medical university
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuyi Zhi
Xuanwu Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
October 11, 2014
First Posted
November 11, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2017
Last Updated
November 11, 2014
Record last verified: 2014-11