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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Segmentectomy

    Procedure/Surgery

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Segmentectomy after Induction TherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Segmentectomy and R0 on final pathology

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). To address the primary objective, the proportion of patients who receive high-quality segmentectomy will be determined immediately at the end of the operation and R0 rates on final pathology will be collected after the surgical operation when pathological reports are completed.

Time frame
Up to 48 hours after date of surgical resection

Secondary outcomes

1

R0 resection rates - on final pathology (post-surgery) if converted to lobectomy

The proportion of patients who received lobectomy with R0 resection on final pathology (post-surgery).

Time frame
Up to 48 hours after date of surgical resection
2

Ability to complete the intended procedure (sublobar anatomic resection)

The proportion of patients with completion of the intended procedure (sublobar anatomic resection) based on the extent of surgical resection immediately at the end of the operation

Time frame
Up to 24 hours after date of surgical resection
3

Conversion to lobectomy in a separate operation from sublobar anatomic resection

The proportion of patients who were converted to lobectomy during the operation or within six weeks after the operation for patients who undergo revision.

Time frame
Up to 6 weeks after date of surgical resection
4

Safety, measured as perioperative outcomes (Post-operative length of stay)

Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative length-of-stay): • Post-operative length of stay defined from the date of surgery until hospital discharge. -Outcome measured in number of days

Time frame
Up to 30 days after date of surgical resection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Collaborator

Source ClinicalTrials.gov
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