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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02824731
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Technische Universität Dresden
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mechthild Krause, Prof.
Principal Investigator Affiliation	University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumors

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: supratentorial, grade III/IV, photon

Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.

Experimental: supratentorial, grade III/IV, proton

Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.

Active Comparator: supratentorial, grade I/II, photon

Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors.

Experimental: supratentorial, grade I/II, proton

Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors.

Active Comparator: infratentorial, photon

Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.

Experimental: infratentorial, proton

Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.

Active Comparator: pre-radiation, photon

> 40Gy in the region of recurrence. Radiation with photons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE).

Experimental: pre-radiation, proton

> 40Gy in the region of recurrence. Radiation with protons normofractionated 54-60 Gy(RBE) or 5 Gy(RBE)/fraction until 30 Gy(RBE) or normofractionated 36 Gy(RBE).

Interventions

Radiation: - Radiation with protons

Radiation: - Radiation with photons

Contact a Trial Team

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