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CHORDOMA study

Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base - clinical phase III study

 

Contactt:


Dr. Matthias Uhl, E-Mail Opens window for sending emailMatthias.Uhl@med.uni-heidelberg.de
Renate Haselmann, E-Mail Opens window for sending emailRenate.Haselmann@med.uni-heidelberg.de



Summary

The study is a prospective randomised clinical phase III trial. The trial will be carriedout at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial.Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed. Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (hypofractionated) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and survival are the secondary end points. Also matters of interest are patterns of recurrence, prognostic factors and plan quality.

 

Most important inclusion criteria

  • Karnofsky Performance Score ≥60%
  • Age >18 years and <80 years
  • Histological confirmation of chordoma with infiltration
  • of the skull base

Most important exclusion criteria

  •  Prior RT of skull base region
  • Other malignancies with disease-free interval < 5 years (excepting pre-cancerous lesions)
  • Participation in another trial
  • Pregnancy
  • Simultaneous CHT or Immunotherapy
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