Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Recruiting Phase 3 Interventional Study
Clinical Stage I Esophageal Adenocarcinoma AJCC v8 Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8 Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Thoracic Esophagus Squamous Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
NRG Oncology · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II) * Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th editi…
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