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

Brain Tumors Clinical Trial

Official title:

Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824731
• Other study ID #: STR - ProtoChoice-Hirn - 2015
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 2029

Study information

• Verified date: April 2024
• Source: Technische Universität Dresden
• Contact: Mechthild Krause, Prof.
• Phone: +49 351 458 5441
• Email: mechthild.krause[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 555
• Est. completion date: October 2029
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

Radiation:
• Radiation with protons

• Radiation with photons

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology	Dresden

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late toxicity as cumulative measure	Events for the endpoint are: any late toxicity CTCAE 4.0 = grade II (except pre-existing conditions); decrease in Quality of life (EORTC-QLQ-C30 and BN20) by >10%; decrease in brain function (MOCA test) by more than 10%	1 year (or at least 6 months)
Secondary	Local tumour control	Local tumour control as Regression or stable disease measured in follow-up MRI	1 year and 2 years
Secondary	Overall survival	Overall survival	1 year and 2 years
Secondary	Acute toxicity	Acute toxicity according to CTCAE4.0 score >/= grade II	3 months after treatment
Secondary	late toxicity as cumulative measure	Events for the endpoint are: any late toxicity CTCAE 4.0 = grade II (except pre-existing conditions); decrease in Quality of life (EORTC-QLQ-C30 and BN20) by >10%; decrease in brain function (MOCA test) by more than 10%	2 years