NCT04944563

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jul 2021Dec 2029

First Submitted

Initial submission to the registry

June 17, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

8.4 years

First QC Date

June 17, 2021

Last Update Submit

April 2, 2022

Conditions

Lung NeoplasmsSurgery

Keywords

Non-small cell lung cancerSegmentectomyLobectomythe middle third of the lung field

Outcome Measures

Primary Outcomes (1)

  • 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

    From date of the recruitment, assessed up to 60 months

Secondary Outcomes (4)

  • 30-day Morbidity and mortality rates

    From date of the recruitment, assessed up to 30 days

  • Pulmonary function in the first year after surgery

    From date of the 3rd, 6th, and 12th month after surgery

  • 3-year Disease-Free-Survival

    From date of the recruitment, assessed up to 36 months

  • 5-year overall Survival

    From date of the recruitment, assessed up to 60 months

Study Arms (2)

Segmentectomy

EXPERIMENTAL

Patients receive segmentectomy

Procedure: Segmentectomy

Lobectomy

ACTIVE COMPARATOR

Patients receive lobectomy

Procedure: Lobectomy

Interventions

SegmentectomyPROCEDURE

Patients receive segmentectomy

Segmentectomy
LobectomyPROCEDURE

Patients receive lobectomy

Lobectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 18-75 years old;
  • mm ≤ tumor size ≤ 20 mm;
  • \< 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.

You may not qualify if:

  • The tumor nodule is located in right middle lobe;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 30442588BACKGROUND

  • 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.

    PMID: 19933688BACKGROUND

  • 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.

    PMID: 31078312BACKGROUND

  • 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.

    PMID: 30390378BACKGROUND

  • 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.

    PMID: 24551879BACKGROUND

  • 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.

    PMID: 33524360BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Mastectomy, SegmentalAnterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Liang Chen, M.D.

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihua Li, M.D.

CONTACT

+86-025-68303743lizhihua_njmu@126.com

Weibing Wu, M.D.

CONTACT

+86-025-68303743wuweibing95@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 29, 2021

Study Start

July 20, 2021

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)