According to the review of the literature, additional radiotherapy seems to improve local control in retrospective studies but this potential advantage must be weighted in regards of potential side-effects. Preoperative adjuvant external beam radiotherapy (EBRT) is best tolerated and can be administered to a total dose of 50.4 Gy. In combined pre operative EBRT and intraoperative radiotherapy (IORT), much of the toxicity may be related to the IORT. This needs a formal phase III randomized study to evaluate the risk/benefit ratio of this approach with a control arm being surgery alone and investigational arm being pre op radiotherapy.

The main objective is to assess whether preoperative radiotherapy, as an adjunct to curative intent surgery, improves the prognosis of patients with RPS.

Primary objective

To assess whether there is a difference in abdominal recurrence-free survival between RPS patients undergoing curative-intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery.

Secondary objectives

To assess whether there is a difference in metastasis-free survival, abdominal recurrence free interval and overall survival between patients undergoing curative-intent surgery alone and those undergoing preoperative radiotherapy followed by curative intent surgery.

To assess tumor response in patients undergoing preoperative radiotherapy To assess the toxicity profile of preoperative radiotherapy given as an “adjuvant”