Re-irradiation of recurrent Glioblastoma withCarbon-Ions (C12) versus Stereotactic Radiotherapy with Photons - A Multicenter, Prospective Randomized Two-Arm Trial
- Conditions
- C71.9Brain, unspecified
- Registration Number
- DRKS00025069
- Lead Sponsor
- Philipps-Universität Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 190
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Toxicity of treatment based on the incidence of grade 3-5 NCI-CTC-AE 5.0<br>- Quality of life (quality of life according to EORTC-QLQ-C30, QLQBN20 and BN) <br>- Cortisone demand (mg/d)<br>- Progression-free survival (PFS) according to RANO<br>- Neurocognitive function (Hopkins Verbal Learning Test-Revised)<br>