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

December 11, 2024 updated by: Mechthild Krause, Technische Universität Dresden

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

555

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
        • Contact:
      • Marburg, Germany, 35043
        • Recruiting
        • University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late toxicity as cumulative measure
Time Frame: 1 year (or at least 6 months)

Events for the endpoint are:

  1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions)
  2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by >10%
  3. decrease in brain function (MOCA test) by more than 10%
1 year (or at least 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year and 2 years
Overall survival
1 year and 2 years
Local tumour control
Time Frame: 1 year and 2 years
Local tumour control as Regression or stable disease measured in follow-up MRI
1 year and 2 years
late toxicity as cumulative measure
Time Frame: 2 years

Events for the endpoint are:

  1. any late toxicity CTCAE 4.0 ≥ grade II (except pre-existing conditions)
  2. decrease in Quality of life (EORTC-QLQ-C30 and BN20) by >10%
  3. decrease in brain function (MOCA test) by more than 10%
2 years
Acute toxicity
Time Frame: 3 months after treatment
Acute toxicity according to CTCAE4.0 score >/= grade II
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

July 2, 2016

First Posted (Estimated)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR - ProtoChoice-Hirn - 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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