Actively Recruiting
Segmentectomy After Induction Therapy (SAINT)
Led by Northwestern University · Updated on 2024-11-14
25
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
R
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Segmentectomy After Induction Therapy (SAINT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-small-cell lung cancer staged 6430ycT1cN0M0 (tumor 3cm or less) after induction therapy
- Received any neoadjuvant chemotherapy, immunotherapy, or chemoimmunotherapy
- Ability and willingness to sign informed consent
- Age 18 years or older
- ECOG performance status less than 3
- Adequate organ function (FEV1 or DLCO 6540%)
- For HIV patients, undetectable viral load for 6 months on therapy
- For hepatitis B patients, undetectable viral load on suppressive therapy
- For hepatitis C patients, treated and cured or undetectable viral load if on treatment
- Prior or concurrent malignancy allowed if not interfering with study
- Candidate for surgical resection under general anesthesia
- Females of child-bearing potential must have a negative pregnancy test prior to registration
You will not qualify if you...
- Prior lung resection or thoracic surgery
- Unrecovered adverse events from prior cancer therapy above Grade 1 (except alopecia)
- Receiving other investigational agents
- Evidence of distant metastases including brain metastases
- Lack of consensus from 2 surgeons on feasibility of segmentectomy
- Tumor involving more than one lobe before induction therapy
- Uncontrolled illnesses such as uncontrolled hypertension, active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia
- Psychiatric or social issues limiting compliance
- Pregnant females
- Malignancy within 3 years (except certain skin, cervical, bladder cancers)
- Active smoking or cessation less than 4 weeks before surgery
- Positive hilar or mediastinal lymph nodes after induction therapy by biopsy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Ankit Bharat, M.D.
CONTACT
N
Nisha Palanisamy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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