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

Technische Universität Dresden

Status: Enrolling

Conditions: Brain Tumors

Treatments: Radiation: Radiation with protons; Radiation: Radiation with photons

Study type: Interventional

Funder types: Other

Identifiers

NCT02824731

STR - ProtoChoice-Hirn - 2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 555 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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555 participants in 8 patient groups

supratentorial, grade III/IV, photon

Active Comparator group

Description:

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

Treatment:

Radiation: Radiation with photons

supratentorial, grade III/IV, proton

Experimental group

Description:

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

Treatment:

Radiation: Radiation with protons

supratentorial, grade I/II, photon

Active Comparator group

Description:

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

Treatment:

Radiation: Radiation with photons

supratentorial, grade I/II, proton

Experimental group

Description:

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

Treatment:

Radiation: Radiation with protons

infratentorial, photon

Active Comparator group

Description:

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

Treatment:

Radiation: Radiation with photons

infratentorial, proton

Experimental group

Description:

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

Treatment:

Radiation: Radiation with protons

pre-radiation, photon

Active Comparator group

Description:

\> 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).

Treatment:

Radiation: Radiation with photons

pre-radiation, proton

Experimental group

Description:

\> 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).

Treatment:

Radiation: Radiation with protons