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Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial.
Seidensaal, K; Kieser, M; Hommertgen, A; Jaekel, C; Harrabi, S B; Herfarth, K; Mechtesheimer, G; Lehner, B; Schneider, M; Nienhueser, H; Fröhling, S; Egerer, G; Debus, J; Uhl, M.
Afiliação
  • Seidensaal K; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. katharina.seidensaal@med.uni-heidelberg.de.
  • Kieser M; Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany. katharina.seidensaal@med.uni-heidelberg.de.
  • Hommertgen A; National Center for Tumor diseases (NCT), Heidelberg, Germany. katharina.seidensaal@med.uni-heidelberg.de.
  • Jaekel C; Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
  • Harrabi SB; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
  • Herfarth K; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
  • Mechtesheimer G; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
  • Lehner B; Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany.
  • Schneider M; National Center for Tumor diseases (NCT), Heidelberg, Germany.
  • Nienhueser H; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany.
  • Fröhling S; Heidelberg Ion-Beam Therapy Center (HIT), Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
  • Egerer G; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
  • Debus J; Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany.
  • Uhl M; National Center for Tumor diseases (NCT), Heidelberg, Germany.
Trials ; 22(1): 134, 2021 Feb 12.
Article em En | MEDLINE | ID: mdl-33579340
ABSTRACT

BACKGROUND:

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. METHODS AND

DESIGN:

We present a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the retroperitoneum will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the safety and feasibility based on the proportion of grade 3-5 toxicity (CTCAE, version 5.0) in the first 12 months after surgery or discontinuation of treatment for any reason related to the treatment. Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study.

DISCUSSION:

The aim of this study is to confirm that hypofractionated, accelerated preoperative radiotherapy is safe and feasible. The rationale for the use of particle therapy is the potential for reduced toxicity. The data will lay the groundwork for a randomized phase III trial comparing hypofractionated proton and carbon ion irradiation with regard to local control. TRIAL REGISTRATION ClinicalTrials.gov NCT04219202 . Retrospectively registered on January 6, 2020.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sarcoma / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Humans Idioma: En Revista: Trials Assunto da revista: MEDICINA / TERAPEUTICA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sarcoma / Terapia Neoadjuvante Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Limite: Humans Idioma: En Revista: Trials Assunto da revista: MEDICINA / TERAPEUTICA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Alemanha