Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-10 @ 4:40 PM
Study NCT ID:
NCT06496659
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Segmentectomy After Induction Therapy (SAINT)
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAINT
Brief 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.
Detailed 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 Stage I patients after neoadjuvant therapy, without necessitating a conversion to lobectomy due to technical complications. Both segmentectomy and lobectomy are considered standard-of-care lung resection procedures.
Recent randomized clinical trials have demonstrated high rates of pathological downstaging for locally advanced lung cancer treated with neoadjuvant chemoimmunotherapy with R0 resection rates of 83.2% to 77.8% in recent historical controls. Other recent trials demonstrated that high-quality segmentectomy is associated with improved overall survival and is now standard-of-care for early-stage lung cancer with small tumor sizes. Given these findings, the logical next step is to determine if the benefits of high-quality segmentectomy may be extended to an increasingly common clinical scenario where locally advanced lung cancers are downstaged to small tumor size after induction therapy.
Recent randomized clinical trials have demonstrated high rates of pathological downstaging for locally advanced lung cancer treated with neoadjuvant chemoimmunotherapy with R0 resection rates of 83.2% to 77.8% in recent historical controls. Other recent trials demonstrated that high-quality segmentectomy is associated with improved overall survival and is now standard-of-care for early-stage lung cancer with small tumor sizes. Given these findings, the logical next step is to determine if the benefits of high-quality segmentectomy may be extended to an increasingly common clinical scenario where locally advanced lung cancers are downstaged to small tumor size after induction therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NU 23L02 | OTHER | Robert H. Lurie Comprehensive Cancer Center of Northwestern University | View |