Proton Beam Therapy to Treat Esophageal Cancer

Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Age Range:18 - Any
Start Date:January 2014
End Date:January 2021
Contact:Jeffrey Bradley, M.D.

Use our guide to learn which trials are right for you!

A Phase I Study of Proton Beam Therapy in the Treatment of Esophageal Cancer

Assess progression-free survival and overall survival of proton beam therapy (PBT) for
patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported
outcomes of PBT for esophageal cancer at 6 months following chemoradiation and
physician-reported toxicity of PBT for esophageal cancer.

Inclusion Criteria:

- Histologically 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 CT w/contrast and EGD to
have stage II or III disease. Endoscopic ultrasound (EUS) is encouraged but not

- Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III
esophageal cancer 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 (Karnofsky > 60%)

- Normal bone marrow and organ function as defined below:

- WBC > 2,500/mcL

- Platelets ≥ 75,000/mcl

- Total bilirubin ≤ 1.5 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

- 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 study entry.
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
Click here to add this to my saved trials