Study Comparing Two Types of Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07718672

Provider View

This clinical trial is testing two different methods of delivering radiation therapy to see which is more effective in treating early-stage non-small cell lung cancer. One method uses a higher dose of radiation focused on the tumor, which may improve control but could also increase side effects.

Patient Parameters

Program Overview

The purpose of this study is to compare two types of radiation therapy for treating early-stage non-small cell lung cancer (NSCLC). One method, called stereotactic ablative radiotherapy (SBRT) with hot spots, delivers a higher dose of radiation directly to the tumor. The other method is the standard SBRT. Researchers want to find out if the higher dose method can better control the tumor and improve patient outcomes, while also monitoring for any increased side effects.

Description

The study aims to evaluate the effectiveness of using higher radiation doses, known as 'hot spots,' in treating early-stage non-small cell lung cancer (NSCLC). Researchers will look at how well this approach controls the tumor, affects survival rates, and impacts patients' quality of life. They will also study any potential side effects and changes in immune cell markers after treatment.

Participants will be randomly assigned to one of two groups. One group will receive standard SBRT, while the other group will receive SBRT with hot spots. Both treatments will be given over 1 to 5 sessions within 11 days. Throughout the study, participants will have CT scans, possibly PET scans, and blood tests. Some may also have lymph node samples taken.

After completing the treatment, participants will have follow-up visits every 3 months for the first year, and then every 3 to 6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 2 or less, indicating good overall health.
  • Diagnosed with early-stage non-small cell lung cancer (NSCLC) that has been confirmed by a biopsy.
  • Can have more than one lung tumor, but each must be confirmed by a biopsy.
  • If previously treated for lung cancer, the new tumor must appear more than 6 months after the last treatment and be considered controlled.
  • Eligible for stereotactic ablative radiotherapy (SABR).
  • Must agree to use effective birth control methods if of childbearing potential.
  • Must understand the study and sign a consent form before participating.

Exclusion Criteria

  • Previous lung cancer treatment within 6 months of starting the study.
  • Mixed types of lung cancer (small cell and non-small cell).
  • History of organ transplant or primary immune deficiency.
  • Previous radiation to the chest that could interfere with the study treatment.
  • Active autoimmune disease requiring treatment in the last 2 years, except for replacement therapies.
  • Known genetic mutations (EGFR or ALK) that affect lung cancer.
  • History of lung diseases like interstitial lung disease or radiation pneumonitis requiring steroids.
  • Pregnant or breastfeeding women.
  • Unable or unwilling to follow study requirements.

Locations

FACILITYZIPCITYSTATE
Roswell Park Cancer Institute14263BuffaloNew York

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.