NCT03185754

Brief Summary

A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 12, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
4 years until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

7.4 years

First QC Date

June 13, 2013

Last Update Submit

November 3, 2020

Conditions

Lung CancerSurgery

Keywords

lung cancersurgerylobectomysublobar resection

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

    5 years

Secondary Outcomes (4)

  • post-operative complication

    3 months

  • Hospitalization time

    3 months

  • Chest tube duration

    3 months

  • post-operative pulmonary function

    6, 12 and 24 months

Other Outcomes (1)

  • pain score

    1, 3, and 7 days

Study Arms (1)

early phase lung cancer

EXPERIMENTAL

sublobar resection and lobectomy

Procedure: Sublobar resectionProcedure: lobectomy

Interventions

Sublobar resectionPROCEDURE

Sublobar resection

early phase lung cancer
lobectomyPROCEDURE

lobectomy

early phase lung cancer

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early non-small cell lung cancer (stage Ia) with diameter of two centimeters or less.
  • Tumor locating at the peripheral lung parenchyma (outer one third in CT imaging).
  • No suspected hilar or mediastinal lymph nodes metastasis in the CT or PET imaging study.

You may not qualify if:

  • Tumor diameter more than 2 centimeter
  • Hilar or mediastinal lymphnode metastasis by the cancer.
  • Patients received previous surgery in the ipsi-lateral lung
  • Lung tumor locating in the central lung parenchyma unable to obtain curative resection by sublobar resection.
  • Patients with poor cardiopulmonary function unsuitable for receiving surgical resection.
  • Patients who have multiple lung cancer or other suspicious lesion in the lung.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (4)

  • Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u.

    PMID: 7677489RESULT

  • Sienel W, Dango S, Kirschbaum A, Cucuruz B, Horth W, Stremmel C, Passlick B. Sublobar resections in stage IA non-small cell lung cancer: segmentectomies result in significantly better cancer-related survival than wedge resections. Eur J Cardiothorac Surg. 2008 Apr;33(4):728-34. doi: 10.1016/j.ejcts.2007.12.048. Epub 2008 Feb 7.

    PMID: 18261918RESULT

  • Kodama K, Doi O, Higashiyama M, Yokouchi H. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg. 1997 Sep;114(3):347-53. doi: 10.1016/S0022-5223(97)70179-X.

    PMID: 9305186RESULT

  • Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2.

    PMID: 11269480RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Lee Jang-Ming

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 14, 2017

Study Start

June 12, 2013

Primary Completion

November 15, 2020

Study Completion

December 31, 2023

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)