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Recruiting NCT05717803

Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)

Phase III Interventional Segmentectomy Lung Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Segmentectomy.
Who it may be relevant to
Registry conditions: Segmentectomy, Lung Adenocarcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial

Overview

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are: * The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm; * The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.

Interventions

  • Procedure Segmentectomy
    The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.

Primary outcome measures

  • 5-year disease-free survival [Time frame: 5 years]
Secondary outcome measures (6)
  • Lung function test [Time frame: Half year and one year after surgical resection]
  • 5-year overall survival [Time frame: 5 years]
  • The site of tumor recurrence and metastasis [Time frame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.]
  • Segmentectomy completion rate [Time frame: From the beginning of the surgery to the end of the surgery.]
  • Radical segmentectomy (R0 resection) completion rate [Time frame: From surgery to the release of the final pathology report, an average of two weeks.]
  • Surgery-related complications [Time frame: From surgery to patient discharge or 30 days after surgery.]

Eligibility criteria

Inclusion criteria

  • 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;
  • Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
  • Ground glass-dominant lung nodules
  • Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm;
  • cN0 without distant metastasis;
  • Tumors could be completely resected assed by surgeons;
  • Not receiving chemotherapy or radiotherapy before.

Exclusion criteria

  • CTR is not 0-0.5, or size is not 2-3cm;
  • Tumors could not be completely resected assed by surgeons;
  • Not lung adenocarcinoma diagnosed cytologically or pathologically;
  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Publications

  • Chen S, Huang Q, Fu F, Wang Z, Zhang Y, Chen H. Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2-3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012). BMJ Open. 2024 Jul 3;14(7):e087088. doi: 10.1136/bmjopen-2024-087088. PMID 38960464

Identifiers

NCT: NCT05717803 · FUSCC2211

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗