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Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)

ConditionBrain Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiation with protons

    Radiation

  • Radiation with photons

    Radiation

Treatment groups

555 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: supratentorial, grade III/IV, photonActive comparator 1 intervention
Group B: supratentorial, grade III/IV, protonExperimental treatment 1 intervention
Group C: supratentorial, grade I/II, photonActive comparator 1 intervention
Group D: supratentorial, grade I/II, protonExperimental treatment 1 intervention
Group E: infratentorial, photonActive comparator 1 intervention
Group F: infratentorial, protonExperimental treatment 1 intervention
Group G: pre-radiation, photonActive comparator 1 intervention
Group H: pre-radiation, protonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

late toxicity as cumulative measure

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%

Time frame
1 year (or at least 6 months)

Secondary outcomes

1

Local tumour control

Local tumour control as Regression or stable disease measured in follow-up MRI

Time frame
1 year and 2 years
2

Overall survival

Overall survival

Time frame
1 year and 2 years
3

Acute toxicity

Acute toxicity according to CTCAE4.0 score \>/= grade II

Time frame
3 months after treatment
4

late toxicity as cumulative measure

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%

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

German Cancer Research Center

Collaborator

National Center for Radiation Research in Oncology Dresden/Heidelberg

Collaborator

Source ClinicalTrials.gov
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