Study on Proton vs. Photon Radiation Therapy for Liver Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03186898

Provider View

This clinical trial is comparing two types of radiation therapy, proton and photon, to see which is more effective in treating liver cancer. Proton therapy may cause less damage to healthy organs and improve survival rates.

Patient Parameters

Program Overview

This study is testing two types of radiation therapy for liver cancer: proton therapy and photon therapy. Both use high-energy beams to target tumors, but proton therapy may be more precise, potentially causing less harm to nearby healthy organs. The trial aims to find out if proton therapy can improve survival rates for liver cancer patients compared to photon therapy.

Description

The main goal of this study is to see if patients with liver cancer live longer when treated with proton therapy compared to photon therapy. Researchers will also look at how long patients live without the cancer getting worse, how the cancer progresses locally, and any side effects from the treatments. They will also assess patients' fatigue levels and overall quality of life.

Patients will be randomly assigned to one of two groups. One group will receive proton therapy, and the other will receive photon therapy. Both treatments will be given over 15-24 days. After treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Have liver cancer that cannot be removed by surgery or has come back locally.
  • Have had a CT scan of the chest, abdomen, and pelvis, or an MRI if CT contrast is not possible.
  • Have at least one tumor that can be measured, with specific size requirements depending on the number of tumors.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Women of childbearing potential must have a negative pregnancy test.
  • Meet specific blood count and organ function criteria.
  • Have had no more than three tumors, with size limits for each.
  • Have not had prior treatment that overlaps with the study treatment area.
  • Provide informed consent to participate.

Exclusion Criteria

  • Have cancer that has spread outside the liver to other organs or large lymph nodes.
  • Have uncontrolled cancer other than the current liver cancer.
  • Have had chemotherapy for liver cancer within two weeks before joining the study.
  • Be pregnant or not willing to use contraception if of childbearing potential.
  • Have HIV with a low CD4 count, unless well-controlled with treatment.
  • Have had previous radiation to the liver that would overlap with the study treatment.
  • Have had a liver transplant.
  • Unable to confirm insurance coverage for the treatment.

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