C71.9
Conditions
Interventions
Group 1: Particle therapy with carbon-ions (C12) using 14 x 3 Gy (Relative Biological Effectiveness)
Group 2: Photon therapy hypofractionated, stereotactic
using 14 x 3 Gy
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. recurrent glioblastoma 2. Karnofsky index of =60% 3. 18 = age > 70 years 4. preceding radiotherapy at primary diagnosis 5. time after re-irradiation >6 months 6. written informed consent
Exclusion criteria
Exclusion criteria: 1. Gliomatosis cerebri 2. distant recurrence 3. involvement of Liquor cerebrospinalis 4. preceding re-radiotherapy of gliablastom 5. patient unable to give consent 6. pregnancy 7. decompensated concomitant disease of the respiratory organs, cardiovascular system, metabolism, hematopoietic system, coagulation or kidney function 8. concurrent participation in other clinical trials that may influence the results of this study 9. active medical implants without authorisation for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is overall survival (OS): Survival is defined as the time from randomisation until death from any cause or censoring of survivors at the time of the last documented observation within the study period, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Toxicity of treatment based on the incidence of grade 3-5 NCI-CTC-AE 5.0 - Quality of life (quality of life according to EORTC-QLQ-C30, QLQBN20 and BN) - Cortisone demand (mg/d) - Progression-free survival (PFS) according to RANO - Neurocognitive function (Hopkins Verbal Learning Test-Revised) | — |
Countries
Germany
Contacts
Public ContactHasan Avci
Outcome results
None listed