Prospective Phase II Trial to Assess Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Multicentric, Prospective Interventional, Randomized, Observer Blind Two Arm (Active Control), Parallel Group Investigator-initiated Phase II Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18 years
• histologically proven low-grade glioma
• indication for definitive or adjuvant radiotherapy
• ability to understand character and personal consequences of the clinical trial
• written informed consent
Locations
Other Locations
Germany
Department of Radiotherapy, University of Heidelberg
RECRUITING
Heidelberg
Contact Information
Primary
Semi Harrabi, MD
semi.harrabi@med.uni-heidelberg.de
+496221 56
Backup
Adriane Lentz-Hommertgen, Phd
adriane.lentz-hommertgen@med.uni-heidelberg.de
+496221 56
Time Frame
Start Date:2023-11-11
Estimated Completion Date:2028-11-11
Participants
Target number of participants:120
Treatments
Active_comparator: Standard treatment plan
Model-based NTCP is calculated after plan approval, however, no further adjustments are to be made to the approved treatment plan
Experimental: Optimized treatment plan
Allocated to Control Calculation of normal tissue complication probability (NTCP) Model-guided replanning. Replanning is performed with Raysearch Raystation. Optimizations objectives are:~1. the optimization objectives that control the maximum dose in the target volume employ a variable, LETd-dependent model for RBE that allows us to include the RBE-variations predicted by the NTCP model~2. the periventricular volume, defined as the volume closer than 4 mm to the ventricular wall, is included into the optimization with a constraint on its Equivalent Uniform Dose (EUD) and with the variable RBE model described above. Thereby, the combined effect of the RBE variation and increased sensitivity of the periventricular volume, as predicted by the NTCP model, is included.~The effectiveness of the re-planning is verified by a second NTCP computation.