Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03801876

Provider View

This clinical trial is exploring whether proton beam therapy or photon radiation therapy is more effective in treating patients with stage I-IVA esophageal cancer. Both methods aim to target the tumor while minimizing damage to healthy tissue.

Patient Parameters

Program Overview

The study aims to find out which type of radiation therapy—proton beam or photon radiation—is better at treating esophageal cancer. Proton therapy uses protons to target the tumor, while photon therapy uses high-energy x-rays. Both methods try to minimize harm to healthy tissues around the tumor. It's not yet clear which method works better, and this trial will help determine that.

Description

The main goals of this study are to see if proton beam radiation therapy (PBT) improves overall survival compared to intensity modulated photon radiation therapy (IMRT) for esophageal cancer, and to check if PBT causes fewer serious heart and lung side effects.

Other goals include comparing the impact of each treatment on patients' symptoms and quality of life, assessing the cost-effectiveness of each treatment, and evaluating how long patients stay in the hospital after surgery. The study will also look at how well each treatment controls the cancer and prevents it from spreading.

Patients in the study will be randomly assigned to one of two groups. One group will receive proton beam therapy, and the other will receive photon radiation therapy. Both groups will also receive chemotherapy with paclitaxel and carboplatin during their radiation treatment. After completing the treatment, patients may have surgery to remove the cancer, depending on their doctor's recommendation. Patients will be followed up regularly for several years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction.
  • Cancer stage I-IVA, excluding T4b, based on specific medical tests.
  • Must have had a surgical consultation to determine if surgery is possible after treatment.
  • May have received a specific type of chemotherapy (FOLFOX) before starting radiation.
  • Good overall health with a performance status of 0, 1, or 2.
  • Adequate blood cell counts and organ function based on recent tests.
  • Negative pregnancy test for women of childbearing potential.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Cancer located in the cervical esophagus.
  • Cancer stage T4b or evidence of cancer spread.
  • Any other active cancer within the last 2 years.
  • Previous radiation therapy to the chest that overlaps with the study treatment area.
  • Severe, uncontrolled health conditions such as infections or heart problems.
  • Pregnant or nursing women.
  • HIV positive with a low CD4 count, unless well-controlled with treatment.
  • Unable to confirm insurance coverage for the treatment.

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