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Segmentectomy for Lung Cancer (SAINT Trial)

N/A
Recruiting
Led By Ankit Bharat, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed non-small-cell lung cancer that is clinically staged as ≤ycT1cN0M0 after receiving induction therapy
Patients must exhibit an ECOG performance status of <3
Must not have
Patients with evidence of distant metastases including brain metastases
Patients with biopsy positive hilar or mediastinal lymph nodes following induction therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)
Awards & highlights

Summary

This trial aims to see if it is possible to safely remove a small part of the lung through surgery for patients with lung cancer who have undergone treatment to shrink the tumor size. The goal is to achieve

Who is the study for?
This trial is for patients with a specific stage of non-small cell lung cancer (NSCLC) who have undergone treatment to shrink the tumor. They must now have a small tumor (2-3cm), no spread to lymph nodes or other parts of the body, and be candidates for a type of surgery called segmentectomy.
What is being tested?
The SAINT trial is testing the success rate of performing segmentectomy, which is a precise surgical procedure to remove part of a lung lobe, in patients whose tumors were reduced by prior therapy to meet certain size criteria.
What are the potential side effects?
While this summary does not provide side effects directly related to the intervention being studied, typical risks from such surgeries may include pain, infection at the incision site, bleeding, and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed and at an early stage after initial treatment.
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I can take care of myself but may not be able to do heavy physical work.
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I am 18 years old or older.
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My lung function is at least 40% of the expected value.
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I have been treated for hepatitis C and am now cured or have an undetectable viral load.
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I have HIV but have been on effective treatment with an undetectable viral load for 6 months.
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My chronic hepatitis B virus infection is under control with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body, including possibly the brain.
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My lymph nodes in the chest area tested positive for cancer after initial treatment.
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I have had surgery on my lungs or chest before.
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My cancer has spread to more than one lobe of an organ before starting treatment.
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I am currently pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to surgical resection (baseline) and after surgical resection (3 months and 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Segmentectomy and R0 on final pathology
Secondary study objectives
Ability to complete the intended procedure (sublobar anatomic resection)
Change in pre-operative FEV1 (forced expiratory volume at one second) at 3 and 6 months for lobectomy and sublobar anatomic resection
Conversion to lobectomy in a separate operation from sublobar anatomic resection
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Segmentectomy after Induction TherapyExperimental Treatment1 Intervention
Surgical intervention (segmentectomy) post induction therapy for Non-Small Cell Lung Cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Segmentectomy
2020
N/A
~40

Find a Location

Who is running the clinical trial?

Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityUNKNOWN
Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,264 Total Patients Enrolled
Ankit Bharat, M.D.Principal InvestigatorNorthwestern University
~17 spots leftby Jul 2029
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