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Open Access Study protocol

A Clinical phase I/II trial to investigate preoperative dose-escalated intensity-modulated radiation therapy (IMRT) and intraoperative radiation therapy (IORT) in patients with retroperitoneal soft tissue sarcoma

Falk Roeder12*, Daniela Schulz-Ertner6, Anna V Nikoghosyan5, Peter E Huber12, Lutz Edler4, Gregor Habl2, Robert Krempien5, Susanne Oertel12, Ladan Saleh-Ebrahimi12, Frank W Hensley2, Markus W Buechler3, Juergen Debus12, Moritz Koch3, Juergen Weitz3 and Marc Bischof2

Author Affiliations

1 Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany

2 Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany

3 Department of Surgery, University of Heidelberg, Heidelberg, Germany

4 Department of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany

5 Department of Radiation Oncology, Helios Clinic Berlin, Berlin, Germany

6 Department of Radiation Oncology, Markus Clinic, Frankfurt, Germany

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BMC Cancer 2012, 12:287  doi:10.1186/1471-2407-12-287

Published: 12 July 2012

Abstract

Background

Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome the dose limitations and resulted in increased outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.

Methods/design

The trial is a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50–56 Gy) followed by surgery and IORT (10–12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.

Discussion

The present study evaluates combined neoadjuvant dose-escalated IMRT followed by surgery and IORT concerning its value for improved local control without markedly increased toxicity.

Trial registration

NCT01566123