PHASE-II TRIAL OF CHEMOTHERAPY, EXTERNAL AND INTRALUMINAL RADIATION PLUS SURGERY FOR ESOPHAGEAL CANCER

A pilot study was performed to assess the feasibility of combining 5-f luorouracil, recombinant alpha-2b-interferon, external radiation thera py and intraluminal high dose rate brachytherapy with surgery in patie nts with locally advanced esophageal carcinoma. 5-fluorouracil, 750 mg m(-2), was administered via continuous 5-day infusion beginning day 1 and weekly thereafter; interferon, 10 mu subcutaneously, was administ ered three times per week beginning day 1 and sargramostin, 5 mu g kg( -1), was administered on days without 5-fluorouracil. External radiati on began on day one using 1.5 daily fractions to 55.5 Gy. Intraluminal brachytherapy was delivered concomitantly once each week for 5 fracti ons of 4 Gy. None of the first eight patients went to surgery. The ext ernal radiation was changed to 1.5 Gy BID to 45 Gy followed by BID int raluminal radiation to 15 Gy. Of the last four patients, there was one case of radiation myelitis. It was found that successful surgery was not possible and excessive toxicities, including radiation myelitis, o ccurred with this aggressive regimen.