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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Carl Gustav Carus, Department of Radiotherapy and Radiation Oncology
RECRUITING
Dresden
University Hospital Gießen and Marburg, Department of Radiotherapy and Radiation Oncology
RECRUITING
Marburg
Contact Information
Primary
Mechthild Krause, Prof.
mechthild.krause@uniklinikum-dresden.de
+49 351 458 5441
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2029-10
Participants
Target number of participants: 555
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden
Collaborators: German Cancer Research Center, National Center for Radiation Research in Oncology Dresden/Heidelberg

This content was sourced from clinicaltrials.gov