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NCT06031246RecruitingPhase 3

Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment (ECTOP-1018)

Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial

Source: ClinicalTrials.gov · Last updated 11 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
634 (estimated)
First submitted
4 Sept 2023
Start date
1 Apr 2023
Primary completion date
1 Jan 2026
Lead sponsor
Fudan University
Diseases
Lung cancer
NCT number
NCT06031246

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 634
  • From 1 Apr 2023 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Other

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chaoqiang Deng
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.