Surgery for early-stage lung cancer with ground glass nodules
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
This study is testing if a lung-sparing surgery called segmentectomy can help people with early-stage lung cancer live longer and breathe better after treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 307 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05717803 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of segmentectomy, a lung-sparing surgical procedure, for patients with ground glass-dominant invasive lung adenocarcinoma measuring 2-3 cm. The study will assess the 5-year disease-free survival rates and post-operative lung function of participants. Eligible patients will undergo segmentectomy and will be monitored for their recovery and long-term outcomes. The trial is part of the Eastern Cooperative Thoracic Oncology Project (ECTOP) and focuses on a specific subset of lung cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with ground glass-dominant lung adenocarcinoma that is 2-3 cm in size and can be completely resected.
Not a fit: Patients with tumors that cannot be completely resected or those who have received prior lung cancer treatments 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 improving survival rates and preserving lung function.
How similar studies have performed: Other studies have shown promising results for segmentectomy in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who sign the informed consent form and are willing to complete the study according to the plan; * Aged from 18 to 80 years old; * ECOG equals 0 or 1; * Not receiving lung cancer surgery before; * Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively; * Ground glass-dominant lung nodules * Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm; * cN0 without distant metastasis; * Tumors could be completely resected assed by surgeons; * Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: * CTR is not 0-0.5, or size is not 2-3cm; * Tumors could not be completely resected assed by surgeons; * Not lung adenocarcinoma diagnosed cytologically or pathologically; * Receiving lung cancer surgery before; * Receiving radiotherapy or chemotherapy.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Haiquan Chen, M.D. — Fudan University
- Study coordinator: Fangqiu Fu, M.D.
- Email: fufangqiu12@163.com
- Phone: +86-13122677592
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.