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Oncology. 2004;67(3-4):215-21.

Phase I study of hyperfractionated radiation therapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer.

Author information

1
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp

Abstract

OBJECTIVE:

This study investigated the maximum-tolerated dose of hyperfractionated radiation therapy with protracted 5-fluorouracil (5-FU) infusion in patients with locally advanced, unresectable pancreatic cancer.

METHODS:

Five cohorts of patients were scheduled to receive escalating doses of hyperfractionated radiation therapy (range, 45.6-64.8 Gy). All patients received two fractions of 1.2 Gy each (separated by 6 h) per day for 5 days a week, and received protracted 5-FU infusion (200 mg/m2/day) during the radiation course. The maximum-tolerated dose was defined as one dose level below the dose at which more than one third of 3-6 patients experienced dose-limiting toxicity.

RESULTS:

Twenty-nine patients were enrolled in this study. The most common toxicities were nausea/vomiting and anorexia. Although 1 patient developed bleeding from a gastric ulcer 3 months after the completion of chemoradiotherapy, the maximum-tolerated dose was not reached even at the highest dose level (level 5, 64.8 Gy). The median survival time was 12.2 months and the 1-year survival rate was 55.0%.

CONCLUSION:

The toxicity associated with our regimen was tolerable up to dose level 5 (64.8 Gy). We are currently conducting a phase II study of this hyperfractionated radiation therapy with protracted 5-FU infusion at a dose of 64.8 Gy.

PMID:
15557781
DOI:
10.1159/000081320
[Indexed for MEDLINE]
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