Trial Information

A Phase I Study of Preoperative Chemoradiation and Intraoperative Radiation Therapy in the Treatment of Retroperitoneal Sarcoma

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of preoperative external
beam radiotherapy when combined with doxorubicin and followed by intraoperative radiotherapy
in patients with resectable primary or recurrent soft tissue sarcoma of the retroperitoneum.
II. Assess radiologic and pathologic response in patients treated with this preoperative
regimen.

OUTLINE: This is a dose-escalation study of external beam radiotherapy. Patients receive
doxorubicin IV bolus followed immediately by doxorubicin IV over 4 days every week for 5
weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks. Patients with
stable or responding disease undergo surgical resection of primary tumor and all adjacent
gross disease approximately 6 weeks after completion of chemoradiotherapy. Patients receive
intraoperative radiotherapy (IORT) to the tumor bed if all gross disease has been resected
and if the area of maximal tumor adherence to the retroperitoneum can be encompassed within
a single IORT field (maximum 15 cm). Cohorts of 3-6 patients receive escalating doses of
external beam radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting
toxicity.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study.