NCT06634966

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-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 solid-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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P50-P75 for phase_3

Timeline
13mo left

Started Jul 2024

Typical duration 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 Progress62%
Jul 2024Jun 2027

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

October 8, 2024

Last Update Submit

October 9, 2024

Conditions

SegmentectomyLung 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.

  • +1 more secondary outcomes

Study Arms (1)

Segmentectomy

EXPERIMENTAL

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

Procedure: Segmentectomy

Interventions

SegmentectomyPROCEDURE

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
Segmentectomy

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;
  • Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
  • Ground glass-dominant lung nodules
  • Consolidation-to-tumor ratio (CTR) ranges from 0.5 to 1, 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 0.5-1, 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Officials

  • Haiquan Chen, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangqiu Fu, M.D.

CONTACT

+86-13122677592fufangqiu12@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
Haiquan Chen

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

CN(1)