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Trial record 1 of 1 for:    protochoice-hirn dresden
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Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)

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ClinicalTrials.gov Identifier: NCT02824731
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg
Information provided by (Responsible Party):
Mechthild Krause, Technische Universität Dresden

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2016
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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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
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Primary Outcome Measures :
  1. late toxicity as cumulative measure [ Time Frame: 1 year after end of treatment ]

    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%


Secondary Outcome Measures :
  1. Local tumour control [ Time Frame: 1 year and 2 years ]
    Local tumour control as Regression or stable disease measured in follow-up MRI

  2. Overall survival [ Time Frame: 1 year and 2 years ]
  3. acute toxicity [ Time Frame: 3 months after treatment ]
    acute toxicity according to CTCAE4.0 score >/= grade II

  4. 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%


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824731


Contacts
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Contact: Mechthild Krause, Prof. +49 351 458 5441 mechthild.krause@uniklinikum-dresden.de

Locations
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Germany
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology Recruiting
Dresden, Germany, 01307
Contact: Mechthild Krause, Prof.    +49 351 458 5441    mechthild.krause@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
German Cancer Research Center
National Center for Radiation Research in Oncology Dresden/Heidelberg
Investigators
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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)
More Information
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Responsible Party: Mechthild Krause, Principal Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02824731    
Other Study ID Numbers: STR - ProtoChoice-Hirn - 2015
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mechthild Krause, Technische Universität Dresden:
brain tumors
proton radiotherapy
photon radiotherapy
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases