Study on Image-Guided Photon or Proton Beam Radiation Therapy for Stage II-IIIB Non-small Cell Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01629498

Provider View

This clinical trial is exploring the safety and effectiveness of two types of advanced radiation therapy—photon and proton beam therapy—in treating patients with stage II-IIIB non-small cell lung cancer. The study aims to find the best dose that targets the tumor while minimizing damage to surrounding healthy tissue.

Patient Parameters

Program Overview

The purpose of this study is to test two advanced types of radiation therapy—photon and proton beam therapy—to see how well they work in treating stage II-IIIB non-small cell lung cancer. These therapies aim to deliver a higher dose of radiation directly to the tumor while protecting nearby healthy tissue. Photon therapy uses x-rays or gamma rays, while proton therapy uses streams of protons to kill cancer cells. The study will determine the best dose and assess the side effects of these treatments.

Description

This study is divided into two phases: Phase I and Phase II.

In Phase I, researchers will determine the highest dose of radiation that can be safely given to patients using either photon or proton beam therapy. This phase will focus on patients with stage II-IIIB non-small cell lung cancer who are also receiving standard chemotherapy.

In Phase II, the study will compare the effectiveness of the two radiation therapies in preventing cancer progression and minimizing severe side effects. Patients will be randomly assigned to receive either photon or proton therapy, both with a technique that boosts the radiation dose to the tumor while sparing healthy tissue.

The study will also look at various factors, such as changes in tumor size, blood markers, and patient symptoms, to understand the overall impact of the treatments. Patients will be monitored regularly after treatment to track their progress and any side effects.

Participants will receive radiation therapy five days a week for up to six weeks, as long as the cancer does not progress and side effects are manageable. After completing the treatment, patients will have follow-up visits to monitor their health and the effectiveness of the therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage II-IIIB non-small cell lung cancer that has not been surgically removed or has returned after surgery or previous radiation therapy.
  • Suitable for combined chemotherapy and radiation therapy as determined by the doctor.
  • General health status score of 70 or higher on the Karnofsky Performance Scale.
  • Weight loss of less than 15% in the three months before diagnosis.
  • May have received initial chemotherapy before being referred for combined treatment.
  • Adequate lung function with a forced expiratory volume of at least 1 liter.
  • Tumor and/or lymph nodes must be visible on scans.
  • Tumor size and location must allow for precise targeting with radiation therapy.
  • No previous radiation to the chest area.
  • Sufficient blood counts and organ function as indicated by specific lab tests.
  • Must sign an informed consent form acknowledging the study's experimental nature.

Exclusion Criteria

  • Previous radiation treatment to areas that would overlap with critical structures like the esophagus, heart, or spinal cord.
  • Tumor that directly invades the esophagus, spinal cord, major blood vessels, or heart.
  • Pregnancy.
  • Women of childbearing potential must use effective birth control.
  • Refusal to participate in the study.

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