MedDataX Logo

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

NCT ID: NCT02824731

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2029-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

brain tumors proton radiotherapy photon radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

supratentorial, grade III/IV, photon

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

Group Type ACTIVE_COMPARATOR

Radiation with photons

Intervention Type RADIATION

supratentorial, grade III/IV, proton

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

Group Type EXPERIMENTAL

Radiation with protons

Intervention Type RADIATION

supratentorial, grade I/II, photon

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

Group Type ACTIVE_COMPARATOR

Radiation with photons

Intervention Type RADIATION

supratentorial, grade I/II, proton

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

Group Type EXPERIMENTAL

Radiation with protons

Intervention Type RADIATION

infratentorial, photon

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

Group Type ACTIVE_COMPARATOR

Radiation with photons

Intervention Type RADIATION

infratentorial, proton

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

Group Type EXPERIMENTAL

Radiation with protons

Intervention Type RADIATION

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).

Group Type ACTIVE_COMPARATOR

Radiation with photons

Intervention Type RADIATION

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).

Group Type EXPERIMENTAL

Radiation with protons

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation with protons

Intervention Type RADIATION

Radiation with photons

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Cancer Research Center

OTHER

Sponsor Role collaborator

National Center for Radiation Research in Oncology Dresden/Heidelberg

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mechthild Krause

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mechthild Krause, Prof.

Role: STUDY_CHAIR

University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology

Dresden, , Germany

Site Status RECRUITING

University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology

Marburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mechthild Krause, Prof.

Role: CONTACT

Phone: +49 351 458 5441

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mechthild Krause, Prof.

Role: primary

Sebastian Adeberg, Prof. Dr.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STR - ProtoChoice-Hirn - 2015

Identifier Type: -

Identifier Source: org_study_id