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

NCT05717803 | Recruiting Phase 3

• 1 other identifier: FUSCC2211
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Segmentectomy; Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 5-year disease-free survival

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

  5 years

Secondary Outcomes (6)

• Lung function test

  Half year and one year after surgical resection

• 5-year overall survival

  5 years

• The site of tumor recurrence and metastasis

  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

  From the beginning of the surgery to the end of the surgery.

• Radical segmentectomy (R0 resection) completion rate

  From surgery to the release of the final pathology report, an average of two weeks.

Study Arms (1)

Segmentectomy

EXPERIMENTAL

Segmentectomy is performed for ground glass-dominant invasive lung cancer with size of 2-3cm.

Procedure: Segmentectomy

Interventions

Segmentectomy PROCEDURE

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.

Also known as: Segment resection, Segment removal

Segmentectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Haiquan Chen, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangqiu Fu, M.D.

CONTACT

+86-13122677592; fufangqiu12@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: January 6, 2023
• First Posted: February 8, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)