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出境医 / 临床实验 / Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC

Study Description
Brief Summary:
Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: segmentectomy Phase 3

Detailed Description:

Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).

Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
  • Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: segmentectomy
Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Procedure: segmentectomy
segmentectomy in Arm I and lobectomy in Arm II

Active Comparator: lobectomy
Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Procedure: segmentectomy
segmentectomy in Arm I and lobectomy in Arm II

Outcome Measures
Primary Outcome Measures :
  1. Relapse-free survival [ Time Frame: 5 years ]
    To evaluate the 5 year relapse-free survival (RFS) rate of two groups.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    To evaluate the 5 year overall survival (OS) rate of two groups.

  2. Pulmonary function [ Time Frame: 6 months and 12 months ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.

  3. the duration of postoperative hospital stay [ Time Frame: an expected average of 5 days ]
    to evaluate the postoperative inpatient days of the two groups.

  4. performance status [ Time Frame: 12 months ]
    to evaluate the postoperative performance status of the two groups by ECOG score standard.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70y
  2. Preoperative criteria:

    ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.

    ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.

  3. Intraoperative criteria:

    ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.

    ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.

    ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.

  4. ECOG performance status 0-2.
  5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
  6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
  7. No prior chemotherapy or radiation therapy.
  8. Lobectomy is tolerated.
  9. Sufficient organ functions.
  10. Written informed consent.

Exclusion Criteria:

  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) multiple cancers.
  3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
  4. Psychosis.
  5. Uncontrollable diabetes mellitus.
  6. History of severe heart disease.
  7. The maximal diameter of GGO≤5mm.
  8. N1, N2, or M1a is confirmed postoperatively.
  9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
  10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
  11. Confirmation of benign disease by postoperative pathologic examination.
  12. Lesion located in the middle lobe.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Weimin Mao, MD +86-571-88122032 maowm1218@163.com
Contact: Changchun Wang, MM +86-571-88128062 ccw7878@163.com

Locations
Layout table for location information
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Contact: Changchun Wang, MM    +86-571-88128062    ccw7878@163.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE June 25, 2015
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Relapse-free survival [ Time Frame: 5 years ]
To evaluate the 5 year relapse-free survival (RFS) rate of two groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • overall survival [ Time Frame: 5 years ]
    To evaluate the 5 year overall survival (OS) rate of two groups.
  • Pulmonary function [ Time Frame: 6 months and 12 months ]
    to evaluate the pulmonary function as measured by expiratory flow rate of the two groups 6 months and 12 months postoperatively.
  • the duration of postoperative hospital stay [ Time Frame: an expected average of 5 days ]
    to evaluate the postoperative inpatient days of the two groups.
  • performance status [ Time Frame: 12 months ]
    to evaluate the postoperative performance status of the two groups by ECOG score standard.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC
Official Title  ICMJE A Phase III Randomized Trial of Anatomical Segmentectomy Versus Lobectomy by Minimal Incision for Stage IA Peripheral Non-Small Cell Lung Cancer (≤ 2cm)
Brief Summary Anatomic segmentectomy may be a less invasive type of surgery than lobectomy for cT1aN0M0 peripheral NSCLC and may retain more pulmonary function. It is not yet known whether anatomic segmentectomy is non-inferior to lobectomy in treating stage IA non-small cell lung cancer. The aim of this study is to investigate whether the outcome of anatomic segmentectomy is similar to lobectomy for peripheral stage IA (≤ 2cm)non-small cell lung cancer (NSCLC).
Detailed Description

Objective: To compare the outcomes(including 5 year relapse free survival rate, 5 year overall survival rate, retaining pulmonary function and the rates of loco-regional and systemic recurrence ) of patients with peripheral stage IA (≤ 2 cm) non-small cell lung cancer undergoing anatomic segmentectomy vs lobectomy. And to evaluate whether the anatomic segmentectomy is an optimal type of surgery for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC).

Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
  • Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.

Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Procedure: segmentectomy
segmentectomy in Arm I and lobectomy in Arm II
Study Arms  ICMJE
  • Experimental: segmentectomy
    Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
    Intervention: Procedure: segmentectomy
  • Active Comparator: lobectomy
    Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
    Intervention: Procedure: segmentectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
610
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-70y
  2. Preoperative criteria:

    ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.

    ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.

  3. Intraoperative criteria:

    ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.

    ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.

    ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.

  4. ECOG performance status 0-2.
  5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
  6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
  7. No prior chemotherapy or radiation therapy.
  8. Lobectomy is tolerated.
  9. Sufficient organ functions.
  10. Written informed consent.

Exclusion Criteria:

  1. Active bacterial or fungous infection.
  2. Simultaneous or metachronous (within the past 5 years) multiple cancers.
  3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
  4. Psychosis.
  5. Uncontrollable diabetes mellitus.
  6. History of severe heart disease.
  7. The maximal diameter of GGO≤5mm.
  8. N1, N2, or M1a is confirmed postoperatively.
  9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
  10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
  11. Confirmation of benign disease by postoperative pathologic examination.
  12. Lesion located in the middle lobe.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weimin Mao, MD +86-571-88122032 maowm1218@163.com
Contact: Changchun Wang, MM +86-571-88128062 ccw7878@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02481661
Other Study ID Numbers  ICMJE ZhejiangCH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhejiang Cancer Hospital
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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