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

Autor: Roeder Falk, Schulz-Ertner Daniela, Nikoghosyan Anna V, Huber Peter E, Edler Lutz, Habl Gregor, Krempien Robert, Oertel Susanne, Saleh-Ebrahimi Ladan, Hensley Frank W, Buechler Markus W, Debus Juergen, Koch Moritz, Weitz Juergen, Bischof Marc
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Zdroj: BMC Cancer, Vol 12, Iss 1, p 287 (2012)
Druh dokumentu: article
ISSN: 1471-2407
DOI: 10.1186/1471-2407-12-287
Popis: 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
Databáze: Directory of Open Access Journals