Proton beam therapy may offer gentler radiation for esophageal cancer
NCT ID NCT03482791
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether proton beam therapy, a precise form of radiation, causes fewer severe side effects than standard radiation for people with esophageal cancer. About 22 patients with stage II or III esophageal cancer will receive proton therapy and report their symptoms and quality of life through surveys. The goal is to see if this approach reduces treatment-related toxicity while still controlling the cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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22 people
The number who actually took part.
- Started
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Apr 2018
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach. * Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines * Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status. * Induction chemotherapy prior to concurrent chemoradiation is allowed. * Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist. * At least 18 years of age. * ECOG performance status \< 2 * Normal bone marrow and organ function as defined below: * WBC \> 2,500/mcL * Platelets \> 75,000/mcl * Total bilirubin \< 1.5 x institutional upper limit of normal (IULN) * AST(SGOT)/ALT(SGPT) \< 3.0 x IULN * Creatinine \< 1.5 x IULN OR Creatinine clearance \> 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document. * English speaker. * Financial coverage for proton therapy. Exclusion Criteria: * Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone. * Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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