Surgery for early-stage lung adenocarcinoma using a less extensive approach
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial
This study is testing if a less invasive lung surgery can be effective for people with early-stage adenocarcinoma, helping them recover better than with traditional surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (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 | NCT06031181 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of sublobar resection for patients diagnosed with adenocarcinoma in situ or minimally invasive adenocarcinoma through intraoperative frozen section analysis. The study will involve patients aged 18 to 80 who have resectable peripheral tumors and have not undergone prior lung cancer surgery. Participants will be monitored for outcomes related to the surgical intervention, focusing on the therapeutic benefits of this less invasive approach compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with resectable peripheral cT1N0M0 lung adenocarcinoma diagnosed via intraoperative frozen section.
Not a fit: Patients with invasive lung adenocarcinoma or those who have previously received lung cancer surgery, chemotherapy, or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive surgical option for patients with early-stage lung adenocarcinoma, potentially leading to better recovery and outcomes.
How similar studies have performed: While this specific approach is being evaluated in this trial, similar studies have shown promise in using less invasive surgical techniques for early-stage lung cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who sign the informed consent form and are willing to complete the study according to the plan; 2. Aged from 18 to 80 years old; 3. ECOG equals 0 or 1; 4. Not receiving lung cancer surgery before; 5. Resectable peripheral cT1N0M0 tumors; 6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules; 7. Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section 8. Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: 1. Not cT1N0M0; 2. Cannot be completely resected by sublobar resection; 3. Invasive lung adenocarcinoma or not lung adenocarcinoma diagnosed cytologically or pathologically; 4. Receiving lung cancer surgery before; 5. Receiving radiotherapy or chemotherapy.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Chaoqiang Deng
- Email: fdudengcq@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.