Primary Tumor Resection for M1a Stage Lung Cancer
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer Metastatic, Surgical Resection. Basic parameters: 18 years — 75 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
Primary Tumor Resection for M1a Stage Lung Cancer With Occult Pleural Dissemination Discovered During Surgery: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
Overview
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.
Primary outcome measures
- Median overall survival [Time frame: About 10months.]
Secondary outcome measures (3)
- 2-year overall survival [Time frame: 2 years]
- 5-year overall survival [Time frame: 5 years]
- FEV1 and FVC [Time frame: 0.5 year]
Eligibility criteria
Inclusion criteria
- Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
- Aged 18-80 years (including critical values) when signing the informed consent form;
- ECOG score 0 or 1;
- No previous lung cancer surgery;
- Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
- Occult pleural metastasis found during surgery;
- First-time treatment and no radiotherapy or chemotherapy.
Exclusion criteria
- The lesion cannot be completely removed surgically;
- Cytological or histological pathology confirms other lung malignancies other than lung cancer;
- Patients who have undergone lung cancer surgery before;
- Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Cancer Center — Shanghai
Identifiers
NCT: NCT06547710 · ECTOP-1023