search
Back to results

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

Primary Purpose

Brain Tumors

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Radiation with protons
Radiation with photons
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring brain tumors, proton radiotherapy, photon radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

supratentorial, grade III/IV, photon

supratentorial, grade III/IV, proton

supratentorial, grade I/II, photon

supratentorial, grade I/II, proton

infratentorial, photon

infratentorial, proton

pre-radiation, photon

pre-radiation, proton

Arm Description

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

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

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

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

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

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

> 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).

> 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).

Outcomes

Primary Outcome Measures

late toxicity as cumulative measure
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 Measures

Local tumour control
Local tumour control as Regression or stable disease measured in follow-up MRI
Overall survival
acute toxicity
acute toxicity according to CTCAE4.0 score >/= grade II
late toxicity as cumulative measure
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%

Full Information

First Posted
May 11, 2016
Last Updated
February 9, 2023
Sponsor
Technische Universität Dresden
Collaborators
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg
search

1. Study Identification

Unique Protocol Identification Number
NCT02824731
Brief Title
Comparison of Proton and Photon Radiotherapy of Brain Tumors (ProtoChoice-Hirn)
Official Title
Comparison of Proton and Photon Radiotherapy of Brain Tumors: Efficiency and Side Effects in Clinical Standard Doses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technische Universität Dresden
Collaborators
German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
brain tumors, proton radiotherapy, photon radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supratentorial, grade III/IV, photon
Arm Type
Active Comparator
Arm Description
Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
Arm Title
supratentorial, grade III/IV, proton
Arm Type
Experimental
Arm Description
Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
Arm Title
supratentorial, grade I/II, photon
Arm Type
Active Comparator
Arm Description
Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients, bening tumors.
Arm Title
supratentorial, grade I/II, proton
Arm Type
Experimental
Arm Description
Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients, bening tumors.
Arm Title
infratentorial, photon
Arm Type
Active Comparator
Arm Description
Radiation with photons normofractionated 54-60 Gy. Not pre-irradiated patients.
Arm Title
infratentorial, proton
Arm Type
Experimental
Arm Description
Radiation with protons normofractionated 54-60 Gy(RBE). Not pre-irradiated patients.
Arm Title
pre-radiation, photon
Arm Type
Active Comparator
Arm Description
> 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).
Arm Title
pre-radiation, proton
Arm Type
Experimental
Arm Description
> 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).
Intervention Type
Radiation
Intervention Name(s)
Radiation with protons
Intervention Type
Radiation
Intervention Name(s)
Radiation with photons
Primary Outcome Measure Information:
Title
late toxicity as cumulative measure
Description
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%
Time Frame
1 year after end of treatment
Secondary Outcome Measure Information:
Title
Local tumour control
Description
Local tumour control as Regression or stable disease measured in follow-up MRI
Time Frame
1 year and 2 years
Title
Overall survival
Time Frame
1 year and 2 years
Title
acute toxicity
Description
acute toxicity according to CTCAE4.0 score >/= grade II
Time Frame
3 months after treatment
Title
late toxicity as cumulative measure
Description
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%
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mechthild Krause, Prof.
Phone
+49 351 458 5441
Email
mechthild.krause@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mechthild Krause, Prof.
Organizational Affiliation
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mechthild Krause, Prof.
Phone
+49 351 458 5441
Email
mechthild.krause@uniklinikum-dresden.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs