Comparing video-assisted surgery to traditional surgery for early-stage lung cancer
Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy
This study is testing if a less invasive video-assisted surgery is just as effective as traditional surgery for people with early-stage lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1086 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03786003 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of video-assisted thoracoscopic surgery (VATS) with traditional thoracotomy for patients with early-stage non-small-cell lung cancer (NSCLC). It focuses on patients with solid clinical stage T1N0M0 NSCLC and evaluates whether VATS is non-inferior to thoracotomy in terms of disease-free survival. The study will also assess overall survival, perioperative complications, pain levels, and quality of life. Patients will undergo routine CT scans and additional tests to confirm their clinical stage before being randomized into one of the two surgical approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with solid, resectable clinical stage T1N0M0 NSCLC.
Not a fit: Patients with non-NSCLC tumors, those requiring different surgical approaches, or those with a history of other malignancies within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for patients with early-stage lung cancer, potentially leading to improved recovery and quality of life.
How similar studies have performed: While many retrospective studies have suggested the effectiveness of VATS, this is one of the first prospective randomized trials specifically addressing its non-inferiority to thoracotomy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical stage T1N0M0 and surgical resectable. * Solid appearance on computed tomography scan. * Age 18 to 75 year. * Signed the informed consent form. Exclusion Criteria: * Not NSCLC in pathological analysis. * Not lobectomy or sublobar resection. * History of other malignant tumors within 5 years. * History of thoracic surgery or unsuitable for VATS. * Previous radiation or chemotherapy.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Shanghai Cancer Center Chen, Ph.D — Shanghai Cancer Center
- Study coordinator: Haoxuan Wu, M.D.
- Email: haoxuanwu@hotmail.com
- Phone: 86-13901770461
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.