Segmentectomy After Induction Therapy (SAINT)
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for t
| Condition(s) | Segmentectomy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis. |
| Who can participate | Inclusion Criteria: * Patients must have histologically confirmed non-small-cell lung cancer that is clinically staged as ≤ycT1cN0M0 (tumor size 3cm or less on greatest dimension measured by cross-sectional imaging) after receiving induction therapy. * Patients may have received any regimen of neoadjuvant chemotherapy, neoadjuvant immunotherapy, or neoadjuvant chemoimmunotherapy. * Patients must have the ability to understand and the willingness to sign a written informed consent document. * Patients must be age ≥ 18 years. * Patients must exhibit a/an ECOG (Eastern Cooperative Oncology Group) performance status of \<3. * Patients must have adequate organ function as defined below: These are guidelines that may or should be modified based on protocol-specific or drug development-specific n |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Lead sponsor | Northwestern University |
| Locations | Chicago, Illinois, United States |
| Start date | 2024-08-02 |
| NCT ID | NCT06496659 |
| Official listing | https://clinicaltrials.gov/study/NCT06496659 |