Brain Tumors
Conditions
Keywords
brain tumors, proton radiotherapy, photon radiotherapy
Brief summary
This protocol compares the toxicity of radiotherapy or radiochemotherapy applied with different radiation modalities - protons or photons. Patients with different kinds of brain tumours and foreseen high-dose radiotherapy can be included. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment.
Detailed description
Non-randomised 2-arm phase II trial on comparison of proton versus photon radiotherapy in brain tumours using standard doses and standard combined chemotherapy protocols. Patients are assigned to the treatment groups by their own choice or availability of the treatment. Patients are stratified into 4 groups, (1) supratentorial grad III/ IV tumours without pre-irradiation; (2) supratentorial grade I/II tumours without pre-irradiation; (3) infratentorial tumours without pre-irradiation; (4) patients with pre-irradiation \>40 Gy in the tumour area. Radiotherapy doses of 54-60 Gy(RBE) are applied in group 1-3 using normal fractionated schedules. In group 4, 30 Gy(RBE)/ 5 Gy(RBE) per fraction or 36 Gy(RBE) with 2 Gy(RBE) per fraction are allowed. Primary endpoint is chronic toxicity and quality of life. The hypothesis of the trial is that the rate of chronic toxicity 1 year after the end of radiotherapy is 15% lower after proton compared to photon treatment. Events for chronic toxicity are toxicities observed later than 3 months after end of radiotherapy and scored CTC-AE4.0 \>grade 2 or a decrease in Quality of life by \>10% (EORTC-QLQ C30 and BN20) or a decrease in neuropsychological functioning by \>10% (MoCa test). All statistical calculations apply to group (1), i.e. supratentorial grade II/IV tumours without pre-irradiation, all other arms are closed when group (1) is closed.
Interventions
RADIATIONRadiation with protons
RADIATIONRadiation with photons
Sponsors
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg
Technische Universität Dresden
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary brain tumor: gliomas (low or high grade), intracerebral meningiomas, pituitary adenomas, craniopharyngioma and other rare brain tumors or * brain tumor recurrence without pre-irradiation or * brain tumor recurrence with pre-irradiation \> 40 Gy in the overlap region with the recurrence region * indication for radiotherapy or radiochemotherapy * Both proton and photon therapy are possible from a medical point of view (that is no standard indication for protons or standard indication for example one-time stereotaxy * age \>= 18 years * general condition ECOG ≤ 2, outpatient basis possible * indication for high dose (except group 4) radiotherapy or radiochemotherapy * capacity to consent and present written informed consent
Exclusion criteria
* lack of capacity to consent or lack of written consent * cerebral lymphomas * brain metastases * very small tumors (for example acoustic neuromas, very small recurrences) for this is a proton therapy from a medical point of view no alternative to a stereotactic radiotherapy * inability to MRI planning (eg. contraindications to performing MRI) * lack of compliance of the patient * lack of or limited possibility of a reproducible storage (eg by severe restriction of mobility of the patient) * missing or limited possibility of regular follow-up visits in accordance with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late toxicity as cumulative measure | 1 year (or at least 6 months) | Events for the endpoint are: 1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions) 2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by \>10% 3. decrease in brain function (MOCA test) by more than 10% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year and 2 years | Overall survival |
| Acute toxicity | 3 months after treatment | Acute toxicity according to CTCAE4.0 score \>/= grade II |
| Local tumour control | 1 year and 2 years | Local tumour control as Regression or stable disease measured in follow-up MRI |
| late toxicity as cumulative measure | 2 years | Events for the endpoint are: 1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions) 2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by \>10% 3. decrease in brain function (MOCA test) by more than 10% |
Countries
Germany
Contacts
Primary ContactMechthild Krause, Prof.
Outcome results
None listed