Surgery for M1a Stage Lung Cancer with Pleural Metastasis
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 study is testing if surgery to remove the main tumor can help people with M1a stage lung cancer that has spread to the pleura live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06547710 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of surgically removing the primary tumor in patients diagnosed with M1a stage lung cancer that has spread to the pleura. The study aims to determine if this surgical intervention can enhance overall survival and improve the quality of life for these patients. Participants will be closely monitored to evaluate outcomes related to their cancer treatment and recovery. The trial is observational, meaning it will collect data without assigning specific treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with newly diagnosed M1a stage lung cancer and no prior treatment.
Not a fit: Patients with other lung malignancies or those who have previously undergone lung cancer surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for patients with advanced lung cancer.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in improving outcomes for patients with metastatic lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fangqiu Fu, MD
- Email: fufangqiu12@163.com
- Phone: 021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.