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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
VATS
Thoracotomy
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung cancer;Elderly;Sublobar resection;Lobectomy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Haidian HospitalRecruiting
  • Peking university people's hospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Sir Run Run Shaw HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lobectomy

Sublobar resection

Arm Description

Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).

Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
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.
Hospitalization time after surgery in Participants
Defined as the time interval from the day of operation to discharge.
Intubation time after surgery in Participants
Defined as the time interval from the day of operation to extubation.
Time To Overall survival Event
The time interval from randomization to death from any cause.
Percentage of Participants With Local Recurrence and Metastasis Event
The ratio of local recurrence and metastasis in 3 years from the day of randomization
Postoperative pulmonary function
The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.
Percentage of Participants With VATS procedure
The ratio of video assisted thoracoscopic surgery in each group.
Scores on the quality of life questionaires
The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.

Full Information

First Posted
January 24, 2015
Last Updated
September 17, 2016
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02360761
Brief Title
Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy
Acronym
STEPS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung cancer;Elderly;Sublobar resection;Lobectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lobectomy
Arm Type
Active Comparator
Arm Description
Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).
Arm Title
Sublobar resection
Arm Type
Experimental
Arm Description
Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.
Intervention Type
Procedure
Intervention Name(s)
VATS
Other Intervention Name(s)
Thoracoscopy
Intervention Description
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
Intervention Type
Procedure
Intervention Name(s)
Thoracotomy
Other Intervention Name(s)
Open surgery
Intervention Description
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
Primary Outcome Measure Information:
Title
Time To Disease free survival Event
Description
The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.
Description
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.
Time Frame
1 months
Title
Hospitalization time after surgery in Participants
Description
Defined as the time interval from the day of operation to discharge.
Time Frame
1 months
Title
Intubation time after surgery in Participants
Description
Defined as the time interval from the day of operation to extubation.
Time Frame
1 months
Title
Time To Overall survival Event
Description
The time interval from randomization to death from any cause.
Time Frame
3 years
Title
Percentage of Participants With Local Recurrence and Metastasis Event
Description
The ratio of local recurrence and metastasis in 3 years from the day of randomization
Time Frame
3 years
Title
Postoperative pulmonary function
Description
The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.
Time Frame
3 years
Title
Percentage of Participants With VATS procedure
Description
The ratio of video assisted thoracoscopic surgery in each group.
Time Frame
1 month
Title
Scores on the quality of life questionaires
Description
The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.
Description
The scores of prospective CGA and 4-yr mortality index to predict the outcome of the elderly.
Time Frame
3 years
Title
The total cost as a measure of the cost/benefit analysis
Description
The cost/benefit analysis of sublobar resection versus lobectomy
Time Frame
3 years
Title
The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5
Description
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.
Time Frame
1 month
Title
The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability.
Description
The morbidity rate after surgery for participants who underwent video-assisted thoracoscopic or open procedures a Measure of Safety and Tolerability.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Wang, M.M.
Phone
+8601088326650
Email
Jwangmd@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Yang, M.D.
Phone
+86010883266557
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Wang, M.M.
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Haidian Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqing Huang
Facility Name
Peking university people's hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang, MD
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fenglei Yu
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhoumiao Chen
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjie Jiao
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Zhao

12. IPD Sharing Statement

Citations:
PubMed Identifier
27053091
Citation
Yang F, Sui X, Chen X, Zhang L, Wang X, Wang S, Wang J. Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial. Trials. 2016 Apr 7;17:191. doi: 10.1186/s13063-016-1312-6.
Results Reference
derived

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

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