Primary Tumor Resection for M1a Stage Lung Cancer (ECTOP-1023)

August 7, 2024 updated by: Haiquan Chen, Fudan University

Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This clinical trial is a single-arm, multicenter, prospective, confirmatory phase II clinical study, which mainly evaluates the efficacy and safety of primary lesion resection for patients with M1a stage lung cancer who have occult pleural dissemination during surgery (Figure 1). Since it is unethical not to perform primary lesion resection during surgery for such patients, this study is a single-arm one. Primary lesion resection should be a resection that can completely remove the primary lesion, including lobectomy and sublobar resection.

Description

Inclusion Criteria:

  1. Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
  2. Aged 18-80 years (including critical values) when signing the informed consent form;
  3. ECOG score 0 or 1;
  4. No previous lung cancer surgery;
  5. Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
  6. Occult pleural metastasis found during surgery;
  7. Preoperative lymph node staging is cN0;
  8. First-time treatment and no radiotherapy or chemotherapy.

Exclusion Criteria:

  1. The lesion cannot be completely removed surgically;
  2. Cytological or histological pathology confirms other lung malignancies other than lung cancer;
  3. Patients who have undergone lung cancer surgery before;
  4. Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median overall survival
Time Frame: About 10months.
Median overall survival for M1a patients underging surgery.
About 10months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: 5 years
5-year overall survival
5 years
2-year overall survival
Time Frame: 2 years
2-year overall survival
2 years
FEV1 and FVC
Time Frame: 0.5 year
Preoperative lung function test
0.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECTOP-1023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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