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Primary Tumor Resection for M1a Stage Lung Cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06547710
Acronym
ECTOP-1023
Enrollment
66
Registered
2024-08-09
Start date
2024-04-01
Completion date
2027-12-01
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Metastatic, Surgical Resection

Brief summary

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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Median overall survivalAbout 10months.Median overall survival for M1a patients underging surgery.

Secondary

MeasureTime frameDescription
2-year overall survival2 years2-year overall survival
5-year overall survival5 years5-year overall survival
FEV1 and FVC0.5 yearPreoperative lung function test

Countries

China

Contacts

CONTACTFangqiu Fu, MD
fufangqiu12@163.com021-64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026