NCT06031246

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment. The main questions it aims to answer are: The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR\>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
634

participants targeted

Target at P75+ for phase_3

Timeline
56mo left

Started Apr 2023

Longer than P75 for phase_3

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 Progress40%
Apr 2023Dec 2030

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

September 4, 2023

Last Update Submit

September 4, 2023

Conditions

Lung AdenocarcinomaLymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

  • 5-year overall survival

    The event is defined as the death due to any causes.

    5 years

Secondary Outcomes (3)

  • Lymph node metastasis

    5 years

  • 5-year recurrence-free survival

    5 years

  • The accuracy of frozen section

    5 years

Study Arms (1)

Selective Lymph Node Dissection

EXPERIMENTAL

Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR\>0.5 Located in the Apical Segment

Procedure: Selective Lymph Node Dissection

Interventions

Selective Lymph Node DissectionPROCEDURE

For patients with NSCLC with CTR\>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected

Selective Lymph Node Dissection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who sign the informed consent form and are willing to complete the study according to the plan;
  • Aged from 18 to 80 years old;
  • ECOG equals 0 or 1;
  • Not receiving lung cancer surgery before;
  • Resectable peripheral cT1N0M0 tumors with CTR\>0.5 located in the apical segment;
  • Non-lepidic predominant invasive NSCLC dignosed by frozen section;
  • Not receiving chemotherapy or radiotherapy before.

You may not qualify if:

  • Not cT1N0M0;
  • Nodules not located in the apical segment or CTR≤0.5;
  • Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;
  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaoqiang Deng

Shanghai, Please Select, 200032, China

RECRUITING

Related Publications (1)

  • Zhang Y, Deng C, Luo X, Yu Y, Zhang Y, Chen H. Protocol of a single-arm, multicenter, phase III trial for selective lymph node dissection in cT1N0M0 invasive non-small cell lung cancer with consolidation-tumor ratio >0.5 located in the apical segment: Eastern Cooperative Thoracic Oncology Projects ECTOP-1018 (SELLAS study). J Thorac Dis. 2024 Nov 30;16(11):8142-8148. doi: 10.21037/jtd-24-1114. Epub 2024 Nov 21.

    PMID: 39678839DERIVED

MeSH Terms

Conditions

Adenocarcinoma of LungLymphatic Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Haiquan Chen, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoqiang Deng, M.D.

CONTACT

+86-13122677592fdudengcq@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director in the Department of Thoracic Surgery, FUSCC

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 11, 2023

Study Start

April 1, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)