CClinicalTrials.gg
Status unknownNCT02288026Updated Nov 11, 2014

Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer

An observational study in Stage IA Non-small Cell Lung Cancer, Adenocarcinoma of the Lung and Squamous Cell Lung Cancer, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-11.

Sponsored by Capital Medical University · Observational

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
630
Ages
60 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.

Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.

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Conditions studied

  • Stage IA Non-small Cell Lung Cancer
  • Adenocarcinoma of the Lung
  • Squamous Cell Lung Cancer

Keywords

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 630 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  1. clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
  2. T≤2cm,N0,M0.
  3. aged 60 to 80 years old.
  4. ECOG≤2.
  5. according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
  6. voluntary participation, signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. pathologic stage is N1, N2, or M1a.
  2. received postoperative adjuvant therapy (chemotherapy or targeted therapy).
  3. radiotherapy or chemotherapy before surgery.
  4. small cell lung cancer
  5. benign lesions
  6. patient unwilling to cooperate with surgery or observation.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
630 participants (estimated)
Patient registry
No

Groups and cohorts

  • Arm I

    Patients undergo lobectomy

  • Arm II

    Patients undergo a wedge resection or anatomical segmentectomy

06

What researchers measure

Primary outcomes

  1. Disease-free survival

    Time frame: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death

Secondary outcomes

  1. Overall survival

    Time frame: at least 5 years

  2. Pulmonary function

    Time frame: Forced expiratory volume in one second, FEV1

07

Study locations

1 of 1 sites recruiting
  • Xuanwu hospital capital medical university
    Beijing, China
    • Xiuyi Zhi · Contact · +86 10 83198287
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02288026
Lead sponsor
Capital Medical University
Collaborators
Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Chest Hospital, Beijing Tongren Hospital, Peking University First Hospital, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Beijing Anzhen Hospital, Peking University Cancer Hospital & Institute
Responsible party
Xiuyi zhi (Chief Physician, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Nov 11, 2014
Start date
Sep 2014
Primary completion
Dec 2017 (estimated)
Last update
Nov 11, 2014

Study contacts

Xiuyi Zhi
Contact
+86 10 83198287
Mu Hu
Contact
+86 10 83198646
Xiuyi Zhi
principal investigator · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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