JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02824731

Studienbeginn:
Juli 2016

Letztes Update:
10.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg,

Studienleiter

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

Kontakt

Mechthild Krause, Prof.
Kontakt:
Phone: +49 351 458 5441
E-Mail: mechthild.krause@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mechthild Krause, Prof.
Phone: +49 351 458 5441
E-Mail: mechthild.krause@uniklinikum-dresden.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. late toxicity as cumulative measure (Time Frame - 1 year (or at least 6 months)):
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:

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):
Overall survival

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: 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%

Studien-Arme

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

Geprüfte Regime

Radiation with protons
Radiation with photons

Quelle: ClinicalTrials.gov

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