Phase II study of docetaxel (Aisu®) combined with three- dimensional conformal external beam radiotherapy in treating patients with inoperable esophageal cancer.

OBJECTIVE This study was designed to investigate treatment efficacy and side effects of concomitant Aisu® (docetaxel) with three-dimensional conformal external beam radiotherapy for the treatment of inoperable patients with esophageal cancer. METHODS Inoperable patients were treated with three-dimensional conformal external beam radiotherapy (5/week, 2 GY/day, and total dose 60GY) plus docetaxel (30-45 mg/m2, iv, d1, 8). RESULTS Twenty eight patients met the study eligibility criteria and the response rate was evaluated according to RICIST guidelines. Among 28 patients, 2 achieved CR, 22 PR, 3 SD and 1 patient was documented PD. Mild gastrointestinal reaction and bone marrow suppression were also documented. All treatment related side effects were tolerable. CONCLUSION Three-dimensional conformal external beam radiotherapy combined with docetaxel is an active and safe regimen for inoperable patients with esophageal cancer.