Study on Proton Beam Radiation Therapy After Surgery for Non-Small Cell Lung Cancer

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT06008730

Provider View

This clinical trial is testing proton beam radiation therapy in patients with non-small cell lung cancer who have had surgery and have cancer in the lymph nodes in the middle of the chest. The study aims to see if this type of radiation can better prevent cancer from coming back compared to traditional radiation.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of proton beam radiation therapy in patients with non-small cell lung cancer (NSCLC) who have had surgery to remove the cancer and have affected lymph nodes in the chest. Proton therapy is a type of radiation that targets cancer cells while sparing healthy tissue. This study will help determine if proton therapy is a better option than conventional radiation after surgery to reduce the risk of cancer returning.

Description

The main goal of this study is to see if proton beam radiation therapy (PBRT) is safe for patients with resected N2 non-small cell lung cancer (NSCLC). Researchers will also look at how the radiation affects the immune system and how well it works in preventing cancer from coming back.

Patients will go through radiation treatment planning and then receive proton beam radiation therapy. Blood samples will be collected to monitor the effects of the treatment. Participants will be followed for 24 months after their first dose of radiation to track their progress and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have had surgery to completely remove the lung cancer and affected lymph nodes.
  • Must have a pathology report showing complete removal of the primary tumor and involvement of at least one chest lymph node, but no cancer in the highest dissected lymph node.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities.
  • Must have a life expectancy of more than 12 weeks.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must have completed all previous cancer treatments at least two weeks before starting radiation.
  • Must be willing and able to comply with study visits and procedures.
  • Must provide informed consent acknowledging understanding of the study and its potential risks and benefits.

Exclusion Criteria

  • Cannot have stage IV cancer.
  • Cannot have had systemic therapy less than two weeks before starting radiation.
  • Cannot have had previous radiation to the chest.
  • Cannot have a history of non-small cell lung cancer other than the current diagnosis.
  • Cannot have small cell lung cancer.
  • Cannot have tumors with specific genetic changes (EGFR or ALK).
  • Cannot have incomplete surgical removal of the cancer.
  • Cannot be receiving other investigational treatments within 21 days before starting the study.
  • Cannot have uncontrolled illnesses or conditions that would interfere with the study.
  • Cannot have significant heart disease or uncontrolled high blood pressure.
  • Cannot be part of vulnerable populations such as minors, pregnant women, or prisoners.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia

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