CompletedEarly Phase 1NCT01781741

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

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.

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

StatusCompleted
PhaseEarly Phase 1
U.S. locations1
SponsorRoswell Park Cancer Institute
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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.

View original record ↗