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Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

Primary Purpose

Lung Neoplasms, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Segmentectomy
Lobectomy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient aged 18-75 years old;
  2. 6 mm ≤ tumor size ≤ 20 mm;
  3. 0.25 < CTR < 1;
  4. Center of tumor located in the middle third of the lung field;
  5. ECOG score of 0,1 or 2;
  6. Lung function (FEV1 ≥ 1 L and ≥ 70%);
  7. Both lung segmentectomy and lobectomy could achieve R0 resection;
  8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
  9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
  10. Single tumor nodule or the concomitant nodule < microinvasive tumor;
  11. Written informed consent.

Exclusion Criteria:

  1. The tumor nodule is located in right middle lobe;
  2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
  3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
  4. A serious mental illness;
  5. Pregnant and lactating women;
  6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
  7. With the history of cerebral infarction or cerebral hemorrhage within 6 months;
  8. With the history of sustained systemic corticosteroid therapy within 1 month;
  9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
  10. Other unsuitable situations;

Sites / Locations

  • Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Segmentectomy

Lobectomy

Arm Description

Patients receive segmentectomy

Patients receive lobectomy

Outcomes

Primary Outcome Measures

5-year Disease-Free Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

Secondary Outcome Measures

30-day Morbidity and mortality rates
The rates of complications and death related to treatment during perioperative period
Pulmonary function in the first year after surgery
The Forced expiratory volume in one second (FEV1) in liter
3-year Disease-Free-Survival
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
5-year overall Survival
The time interval from randomization to death caused by any reason

Full Information

First Posted
June 17, 2021
Last Updated
April 2, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04944563
Brief Title
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
Official Title
Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
December 1, 2029 (Anticipated)
Study Completion Date
December 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
Detailed Description
Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Surgery
Keywords
Non-small cell lung cancer, Segmentectomy, Lobectomy, the middle third of the lung field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Segmentectomy
Arm Type
Experimental
Arm Description
Patients receive segmentectomy
Arm Title
Lobectomy
Arm Type
Active Comparator
Arm Description
Patients receive lobectomy
Intervention Type
Procedure
Intervention Name(s)
Segmentectomy
Intervention Description
Patients receive segmentectomy
Intervention Type
Procedure
Intervention Name(s)
Lobectomy
Intervention Description
Patients receive lobectomy
Primary Outcome Measure Information:
Title
5-year Disease-Free Survival
Description
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Time Frame
From date of the recruitment, assessed up to 60 months
Secondary Outcome Measure Information:
Title
30-day Morbidity and mortality rates
Description
The rates of complications and death related to treatment during perioperative period
Time Frame
From date of the recruitment, assessed up to 30 days
Title
Pulmonary function in the first year after surgery
Description
The Forced expiratory volume in one second (FEV1) in liter
Time Frame
From date of the 3rd, 6th, and 12th month after surgery
Title
3-year Disease-Free-Survival
Description
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
Time Frame
From date of the recruitment, assessed up to 36 months
Title
5-year overall Survival
Description
The time interval from randomization to death caused by any reason
Time Frame
From date of the recruitment, assessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18-75 years old; 6 mm ≤ tumor size ≤ 20 mm; 0.25 < CTR < 1; Center of tumor located in the middle third of the lung field; ECOG score of 0,1 or 2; Lung function (FEV1 ≥ 1 L and ≥ 70%); Both lung segmentectomy and lobectomy could achieve R0 resection; No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy; No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis; Single tumor nodule or the concomitant nodule < microinvasive tumor; Written informed consent. Exclusion Criteria: The tumor nodule is located in right middle lobe; A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer); Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on; A serious mental illness; Pregnant and lactating women; Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months; With the history of cerebral infarction or cerebral hemorrhage within 6 months; With the history of sustained systemic corticosteroid therapy within 1 month; The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA Other unsuitable situations;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihua Li, M.D.
Phone
+86-025-68303743
Email
lizhihua_njmu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weibing Wu, M.D.
Phone
+86-025-68303743
Email
wuweibing95@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Chen, M.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Li, M.D.
Phone
+86-02568303743
Email
lizhihua_njmu@126.com
First Name & Middle Initial & Last Name & Degree
Liang Chen, M.D.
First Name & Middle Initial & Last Name & Degree
Weibing Wu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30442588
Citation
Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12.
Results Reference
background
PubMed Identifier
19933688
Citation
Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22.
Results Reference
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PubMed Identifier
31078312
Citation
Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9.
Results Reference
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PubMed Identifier
30390378
Citation
Wu WB, Xia Y, Pan XL, Wang J, He ZC, Xu J, Wen W, Xu XF, Zhu Q, Chen L. Three-dimensional navigation-guided thoracoscopic combined subsegmentectomy for intersegmental pulmonary nodules. Thorac Cancer. 2019 Jan;10(1):41-46. doi: 10.1111/1759-7714.12897. Epub 2018 Nov 3.
Results Reference
background
PubMed Identifier
24551879
Citation
Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094.
Results Reference
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PubMed Identifier
33524360
Citation
Wu W, He Z, Xu J, Wen W, Wang J, Zhu Q, Chen L. Anatomical Pulmonary Sublobar Resection Based on Subsegment. Ann Thorac Surg. 2021 Jun;111(6):e447-e450. doi: 10.1016/j.athoracsur.2020.10.083. Epub 2021 Jan 30.
Results Reference
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Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

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