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Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial

Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence rates but the efficacy of this strategy has not been definitely established. As treatment tol...

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Main Authors: Seidensaal, Katharina (Author) , Kieser, Meinhard (Author) , Hommertgen, Adriane (Author) , Jäkel, Cornelia (Author) , Harrabi, Semi B. (Author) , Herfarth, Klaus (Author) , Mechtersheimer, Gunhild (Author) , Lehner, Burkhard (Author) , Schneider, Martin (Author) , Nienhüser, Henrik (Author) , Fröhling, Stefan (Author) , Egerer, Gerlinde (Author) , Debus, Jürgen (Author) , Uhl, Matthias (Author)
Format: Article (Journal)
Language:English
Published: 12 February 2021
In: Trials
Year: 2021, Volume: 22, Pages: 1-9
ISSN:1468-6694
DOI:10.1186/s13063-021-05069-z
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s13063-021-05069-z
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Author Notes:K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S.B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fröhling, G. Egerer, J. Debus and M. Uhl

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520 |a Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence rates but the efficacy of this strategy has not been definitely established. As treatment tolerability is more favorable with preoperative radiotherapy, normofractionated neoadjuvant treatment is the current approach. The final results of the prospective, randomized STRASS (EORTC 62092) trial, which compared the efficacy of this combined treatment to that of surgery alone, are still awaited; preliminary results presented at the 2019 ASCO Annual Meeting indicated that combined treatment is associated with better local control in patients with liposarcoma (74.5% of the cohort, 11% benefit in abdominal progression free survival after 3 years, p = 0.049). Particles allow better sparing of surrounding tissues at risk, e.g., bowel epithelium, and carbon ions additionally offer biologic advantages and are preferred in slow growing tumors. Furthermore, hypofractionation allows for a significantly shorter treatment interval with a lower risk of progression during radiotherapy. 
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