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Brain TumorsNCT02824731

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

A study testing Radiation with protons and Radiation with photons in people with Brain Tumors, run by Technische Universität Dresden at 2 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumors
What is being tested?
Radiation with protons and Radiation with photons
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
555 participants
Where
2 sitesGermany
Study dates
Jul 2016to Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mechthild Krause, Prof. contact

+49 351 458 5441

mechthild.krause@uniklinikum-dresden.de

Germany2 sites, 2 recruiting

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

    Dresden, 01307

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

    Recruiting

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

    Marburg, 35043

    Sebastian Adeberg, Prof. Dr., +496421-5868074, Studien.Radioonkologie.MR@uk-gm.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Brain Tumors
Being tested
Radiation with protons, Radiation with photons
Keywords
brain tumors, proton radiotherapy, photon radiotherapy
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation with protonsRadiation

  • Radiation with photonsRadiation

Study groups in NCT02824731
Study groupRoleWhat they receive
supratentorial, grade III/IV, photonActive comparatorRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
Receives: Radiation: Radiation with photons
supratentorial, grade III/IV, protonExperimentalRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
Receives: Radiation: Radiation with protons
supratentorial, grade I/II, photonActive comparatorRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors.
Receives: Radiation: Radiation with photons
supratentorial, grade I/II, protonExperimentalRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors.
Receives: Radiation: Radiation with protons
infratentorial, photonActive comparatorRadiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
Receives: Radiation: Radiation with photons
infratentorial, protonExperimentalRadiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
Receives: Radiation: Radiation with protons
pre-radiation, photonActive comparator> 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).
Receives: Radiation: Radiation with photons
pre-radiation, protonExperimental> 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).
Receives: Radiation: Radiation with protons

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. late toxicity as cumulative measure

    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%

    Measured: 1 year (or at least 6 months)

Secondary outcomes (4)

  1. Local tumour control

    Local tumour control as Regression or stable disease measured in follow-up MRI

    Measured: 1 year and 2 years

  2. Overall survival

    Overall survival

    Measured: 1 year and 2 years

  3. Acute toxicity

    Acute toxicity according to CTCAE4.0 score >/= grade II

    Measured: 3 months after treatment

  4. late toxicity as cumulative measure

    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%

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
555 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02824731
Sponsor's protocol ID
STR - ProtoChoice-Hirn - 2015
Status last verified
Dec 2024
First submitted
11 May 2016
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiation with protons and Radiation with photons in people with Brain Tumors, run by Technische Universität Dresden at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mechthild Krause, Prof. (+49 351 458 5441, mechthild.krause@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

late toxicity as cumulative measure (time frame: 1 year (or at least 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02824731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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