Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy (STEPS)

September 17, 2016 updated by: Jun Wang, Peking University People's Hospital

Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial

The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?

Study Type

Interventional

Enrollment (Anticipated)

339

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fan Yang, M.D.
  • Phone Number: +86010883266557

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jun Wang, MD
      • Beijing, China
        • Recruiting
        • Beijing Haidian Hospital
        • Contact:
          • Yuqing Huang
      • Changsha, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Fenglei Yu
      • Hangzhao, China
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Zhoumiao Chen
      • Qingdao, China
        • Recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
          • Wenjie Jiao
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Song Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 70 years or older

  • Preoperative criteria (contrast-enhanced Computed tomography scan)

    • Suspected non-small cell lung cancer
    • Clinical stage ⅠA, i.e. T1N0M0 (tumor diameter ≤3 cm, surrounded by visceral pleura, short-axis of lymph node <1 cm or cold lymph nodes on PET scan)
    • The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions
    • Eligible for sublobar resection with sufficient margin

  • Intraoperative criteria

    • Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasive adenocarcinomas defined by The International Association for the Study of Lung Cancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)
    • Pathological exclusion of suspected lymph nodes involvement
    • Feasible to perform sublobar resection in terms of surgical margin requirement

  • General criteria

    • Must sign informed consent by the patient or his/her entrusted party
    • Must complete 4-year mortality index and comprehensive geriatric assessment(CGA) if necessary
    • The physiological reservation can tolerate lobectomy

Exclusion Criteria:

  • Unable to comply with the study procedure
  • Past thoracic surgery history, except for diagnostic thoracoscopy
  • Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ
  • Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases
  • Uncontrollable infections
  • Coexisting small cell lung cancer
  • Psychiatric diseases diagnosed
  • Other circumstances which is deemed inappropriate for enrollment by the researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lobectomy
Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).
Procedure: VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Other Names:
  • Thoracoscopy
Procedure: Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Other Names:
  • Open surgery
Experimental: Sublobar resection
Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
Procedure: VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Other Names:
  • Thoracoscopy
Procedure: Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Other Names:
  • Open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Disease free survival Event
Time Frame: 3 years
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
Time Frame: 1 months
Perioperative complication is defined as the complication occurred after surgery and before discharge, or within 30 days postoperatively. Death cases during this period should be recorded as perioperative death.
1 months
Hospitalization time after surgery in Participants
Time Frame: 1 months
Defined as the time interval from the day of operation to discharge.
1 months
Intubation time after surgery in Participants
Time Frame: 1 months
Defined as the time interval from the day of operation to extubation.
1 months
Time To Overall survival Event
Time Frame: 3 years
The time interval from randomization to death from any cause.
3 years
Percentage of Participants With Local Recurrence and Metastasis Event
Time Frame: 3 years
The ratio of local recurrence and metastasis in 3 years from the day of randomization
3 years
Postoperative pulmonary function
Time Frame: 3 years
The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.
3 years
Percentage of Participants With VATS procedure
Time Frame: 1 month
The ratio of video assisted thoracoscopic surgery in each group.
1 month
Scores on the quality of life questionaires
Time Frame: 3 years
The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.
Time Frame: 3 years
The scores of prospective CGA and 4-yr mortality index to predict the outcome of the elderly.
3 years
The total cost as a measure of the cost/benefit analysis
Time Frame: 3 years
The cost/benefit analysis of sublobar resection versus lobectomy
3 years
The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5
Time Frame: 1 month
The radiologic character of C/T>0.5 has been considered as a pathologically noninvasive lung cancer. and the rate of pathologically noninvasive lung cancer will be used as a measure for the relation between the radiologic / pathologic character of primary non-small-cell lung cancer and prognosis.
1 month
The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability.
Time Frame: 3 years
The morbidity rate after surgery for participants who underwent video-assisted thoracoscopic or open procedures a Measure of Safety and Tolerability.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Jun Wang, M.M., Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 24, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 17, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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