Trial Information

Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer

OBJECTIVES: I. Evaluate the quality of life of patients with esophageal cancer randomized on
protocol CALGB C9781 to treatment with surgery alone vs trimodal therapy combining
preoperative chemotherapy and radiation therapy in addition to surgery. II. Examine the
incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy
in the treatment of esophageal cancer. III. Examine the incremental cost per
quality-adjusted life year (QALY) of preoperative chemotherapy and radiation therapy in the
treatment of esophageal cancer.

OUTLINE: This is a companion study to CALGB C9781, a phase III randomized study. Prior to
treatment on CALGB C9781, patients complete forms assessing quality of life, psychological
functioning, specific areas of dysfunction, resource use, and time lost from work;
subsequent assessments are completed by telephone interview at 1, 2, 6, 12, 18, and 24
months after the initiation of study treatment, regardless of disease status (patients with
hearing impairment and those speaking only a translatable foreign language may mail
responses). Patients also keep a diary of medical resource utilization at sites other than
the treating institution.

PROJECTED ACCRUAL: Approximately 180 patients will be accrued to this study.