Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

Study summary

This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedtherapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) and quality-of-life assessment

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 22, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Early Phase 1
Sponsor: Roswell Park Cancer Institute
Interventions being studied: Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT); Other: quality-of-life assessment

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→Recurrent or relapsed→

Treatment approach

Radiation therapy→Surgery→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV \[to include limited volume metastases such as brain, bone, adrenal\])
Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure
Patients with chemotherapy prior to TEMLA are eligible

Reasons someone may not be able to joinExclusion criteria

Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly
If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Any condition which the investigator's opinion deems the patient ineligible
Received an investigational agent within 30 days prior to enrollment

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2022. Always confirm current availability with the study team.

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