This randomized phase IIB trial studies how well proton beam radiation therapy and intensity-modulated radiation therapy work in treating patients with esophageal cancer. Specialized radiation therapies, such as proton beam radiation therapy and intensity-modulated radiation therapy, that deliver a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether proton beam radiation therapy is more effective than intensity-modulated radiation therapy in treating esophageal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01512589.
PRIMARY OBJECTIVES:
I. Progression-free survival (PFS).
II. Total toxicity burden (TTB).
SECONDARY OBJECTIVES:
I. Patient reported outcome measures of symptoms using MD Anderson Symptom Inventory (MDASI) and European Quality of Life-5 Dimensions (EQ5D).
II. Physician reported toxicity using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
III. Quality-adjusted-life-years (QALY) comparison between proton beam therapy (PBT) and intensity-modulated radiation therapy (IMRT).
IV. Pathologic response rate.
V. Cost-benefit economic analysis of treatment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel intravenously (IV) and fluorouracil IV at the discretion of the treating physician and undergo PBT once daily (QD) 5 days a week for a total of 28 fractions.
ARM II: Patients receive docetaxel IV and fluorouracil IV at the discretion of the treating physician and undergo IMRT QD 5 days a week for a total of 28 fractions.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3-4 months for 2 years, and then every 4-6 months for 3 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSteven H. Lin
