Segmentectomy After Induction Therapy (SAINT): Phase II Single Arm Trial Evaluating Segmentectomy in Accomplishing R0 Resection for Patients With Lung Cancer Treated With Neoadjuvant Therapy
Northwestern University
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.
Description
With the advent of effective neoadjuvant therapies, many patients with Stage II or III lung cancer are being downstaged to Stage I. Recent studies have shown that sublobar resections, especially segmentectomy, offer superior long-term survival and quality of life for patients with Stage I cancer. However, aside from isolated cases, the safety and feasibility of performing segmentectomy on patients who were initially diagnosed with advanced-stage cancer but were later downstaged to Stage I remain unexplored. Thus, our hypothesis is that segmentectomy can be safely executed in these downstaged S…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureSegmentectomy
A segmentectomy is a surgical procedure to remove a segment of the lung. This surgery will be done on patients who have completed neoadjuvant therapy for diagnosis of Non-Small Cell Lung Cancer.
Location
- Northwestern UniversityChicago, Illinois