Randomized Phase II Study Evaluating a Carbon Ion Boost Applied After Combined Radiochemotherapy With Temozolomide Versus a Proton Boost After Radiochemotherapy With Temozolomide in Patients With Primary Glioblastoma
The purpose of the trial is to compare a carbon ion boost to a proton boost delivered to the
macroscopic tumor in combination with combined radiochemotherapy with TMZ in patients with
The aim of the study is to compare overall survival as a primary endpoint, and progression
free survival, toxicity and safety as secondary endpoints.
Focus of the analysis is to evaluate the change in overall survival and local control by
carbon ion radiotherapy. Therefore, the aim of the trial is to evaluate the improvement in
outcome due to effect of the altered biology of carbon ions on GBM. Chemotherapy with TMZ is
considered standard treatment and is administered continuously as it would be applied in
standard patient care outside any trial.
Trial Design The trial will be performed as a single-center two-armed randomized Phase II
Patients fulfilling the inclusion criteria will be randomized into two arms:
Arm A - Experimental Arm Carbon Ion Radiation Therapy as a Boost to the macroscopic tumor
Total Dose 18 Gy E, 6 fractions, 3 Gy E single dose
Arm B - Standard Arm Proton Radiation Therapy as a Boost to the macroscopic tumor Total Dose
10 Gy E, 5 fractions, 2 Gy E single dose
Standard chemotherapy with TMZ will be continued during the experimental and standard arm in
conventional dosing of 75 mg/m2 per day.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Germany: Federal Office for Radiation Protection