Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.

Eligibility criteria

Qualifiers

Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)

History/physical examination

Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast

For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration

Disqualifiers

Cervical esophageal cancers arisen from 15-18 cm from the incisors

Patients with T4b disease according to the AJCC 8th edition

Definitive clinical or radiologic evidence of metastatic disease

Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Capecitabine
  • Carboplatin
  • Computed Tomography
  • Docetaxel
  • Esophagectomy
  • Fluorouracil
  • Intensity-Modulated Radiation Therapy
  • Leucovorin Calcium
  • Oxaliplatin
  • Paclitaxel
  • Positron Emission Tomography
  • Proton Beam Radiation Therapy
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator