NCT03801876 · NRG Oncology
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
DRUG
Capecitabine
Oral
DRUG
Carboplatin
Given IV
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
DRUG
Docetaxel
IV
PROCEDURE
Esophagectomy
Undergo esophagectomy
DRUG
Fluorouracil
IV
RADIATION
Intensity-Modulated Radiation Therapy
Undergo IMRT
DRUG
Leucovorin Calcium
Oral
DRUG
Oxaliplatin
IV
DRUG
Paclitaxel
Given IV
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
RADIATION
Proton Beam Radiation Therapy
Undergo PBT
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Overall survival (OS)
Time frame: From the date of randomization to the date of death due to any cause or date of last follow-up for patients without an OS event reported. This analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion
Will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test.
Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment
Time frame: From baseline up to 8 years
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Difference in proportion of defined cardiopulmonary AEs will be analyzed with a chi-squared test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 edition based on the following diagnostic workup:
- 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
- For patients who DID receive induction chemotherapy, scan must occur:
- Within 30 days after final induction chemotherapy dose; OR
- Within 30 days prior to Step 1 registration
- Note: Patients who had prior endoscopic mucosal resection (EMR) with a di
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Little Rock, Arkansas
- Coral Gables, Florida
- Deerfield Beach, Florida
- Doral, Florida
- Miami, Florida
- Orlando, Florida
- Plantation, Florida
- Atlanta, Georgia
- Alton, Illinois
- DeKalb, Illinois
And 68 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations