A Phase III Study Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

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Full Title

Phase III Randomized Trial of Proton Beam Therapy (PBT) versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer (NRG-GI006) (CIRB)

Purpose

The purpose of this study is to compare proton beam radiation therapy with intensity-modulated radiation therapy (IMRT) in patients with stage I-IVA esophageal cancer. Both approaches send radiation inside the body to a tumor without damaging much of the healthy tissue around it. However, proton beam radiation therapy uses protons while IMRT uses photons (high-energy x-rays).

It is not yet known whether proton beam therapy or intensity-modulated photon radiation therapy will work better in treating patients with esophageal cancer. Patients in this study will be randomly assigned to receive either proton beam therapy or IMRT in addition to chemotherapy. Within 4-8 weeks after completing chemotherapy and radiation therapy, some patients may undergo esophageal cancer surgery.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I-IVA adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction (where the esophagus meets the stomach).
  • Prior induction chemotherapy is permitted but must have been completed at least 10 days and no more than 90 days before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Abraham Wu at 212-639-5257.

Protocol

21-291

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

ClinicalTrials.gov ID

NCT03801876