Proton Beam Therapy in the Treatment of Esophageal Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:April 19, 2018
End Date:April 30, 2022
Contact:Jeffrey Bradey, M.D., FACR, FASTRO
Email:jbradley@wustl.edu
Phone:314-747-1786

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

The investigators plan to include both operable and inoperable patients with esophagus cancer
in this prospective trial. Since both proton and photon treatments are biologically
equivalent, the investigators do not expect a difference in tumor control compared to
intensity modulated radiation therapy (IMRT). The investigators have a prospective experience
of physician-reported toxicity and patient outcome using IMRT for patients with inoperable
esophagus cancer that will serve as a comparison group. For the resectable patients receiving
trimodality therapy (chemoradiation followed by surgery), the investigators will carefully
track toxicity and patient outcomes prospectively. The central hypothesis is that the
biologic efficacy for tumor control should be similar between protons and photons, and
therefore survival measures should be similar between the two groups, but that the main
difference lies in the total severe toxicities experienced by the patients undergoing
therapy.


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

- 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

- 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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Jeffrey Bradley, M.D, FACR, FASTRO
Phone: 314-747-1786
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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