Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
United States147 participantsStarted 2012-04-30
Plain-language summary
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer.
PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \>/= 18
✓. Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
✓. Potentially resectable or unresectable esophageal cancer patients
✓. Induction chemotherapy prior to concurrent chemoradiation allowed
✓. Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
✓. Performance status of Karnofsky Performance Scale (KPS) \>/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
✓. Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
✓. Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
. Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible.
✕. Pregnant or breast-feeding females
✕. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration
✕. Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.