Segmentectomy After Induction Therapy (SAINT)
ConditionSegmentectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients who have had prior lung resection or thoracic surgery.
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other investigational agents.
Patients with evidence of distant metastases including brain metastases will be excluded from this study because they will not benefit from surgical resection.
Trial design
Treatments tested in this trial
- Segmentectomy
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwestern University
Lead sponsor
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Collaborator
Source ClinicalTrials.gov