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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Recruiting

CT.gov ID

NCT02824731

Collaborator

German Cancer Research Center (Other), National Center for Radiation Research in Oncology Dresden/Heidelberg (Other)

346

Enrollment

Location

Arms

120

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumors	Radiation: Radiation with protons Radiation: Radiation with photons	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

346 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: supratentorial, grade III/IV, photon Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.	Radiation: Radiation with photons
Experimental: supratentorial, grade III/IV, proton Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.	Radiation: Radiation with protons
Active Comparator: supratentorial, grade I/II, photon Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors.	Radiation: Radiation with photons
Experimental: supratentorial, grade I/II, proton Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors.	Radiation: Radiation with protons
Active Comparator: infratentorial, photon Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.	Radiation: Radiation with photons
Experimental: infratentorial, proton Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.	Radiation: Radiation with protons
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).	Radiation: Radiation with photons
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).	Radiation: Radiation with protons

Outcome Measures

Primary Outcome Measures

late toxicity as cumulative measure [1 year after end of treatment]
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%

Secondary Outcome Measures

Local tumour control [1 year and 2 years]
Local tumour control as Regression or stable disease measured in follow-up MRI
Overall survival [1 year and 2 years]
acute toxicity [3 months after treatment]
acute toxicity according to CTCAE4.0 score >/= grade II
late toxicity as cumulative measure [2 years]
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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary brain tumor: gliomas (low or high grade), intracerebral meningiomas, pituitary adenomas, craniopharyngioma and other rare brain tumors
brain tumor recurrence without pre-irradiation
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology	Dresden		Germany	01307

Sponsors and Collaborators

Technische Universität Dresden
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg

Investigators

Study Chair: Mechthild Krause, Prof., University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mechthild Krause, Principal Investigator, Technische Universität Dresden

ClinicalTrials.gov Identifier:

NCT02824731

Other Study ID Numbers:

STR - ProtoChoice-Hirn - 2015

First Posted:

Jul 7, 2016

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mechthild Krause, Principal Investigator, Technische Universität Dresden

brain tumors

proton radiotherapy

photon radiotherapy

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Mar 9, 2021