To hear about similar clinical trials, please enter your email below
Trial Title:
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
NCT ID:
NCT05964569
Condition:
Low Grade Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized, observer blind two arm (active control), parallel group
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
model-guided optimization of treatment plan
Description:
original treatmant plans are optimized based on model-based NTCP
Arm group label:
Optimized treatment plan
Intervention type:
Other
Intervention name:
standard treatment plan, no optimization
Description:
original treatment plans are not optimized
Arm group label:
Standard treatment plan
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
Detailed description:
Since patients with low grade glioma are expected to become long-term survivors, the
prevention of long-term sequelae is particularly important. In addition to disease
progression, also treatment related side effects such as decline of neurocognitive
function, endocrine impairment or sensorineural deficits can have a negative impact on
patient's quality of life.
Owing to the biophysical properties of protons with an inverse depth dose profile
compared to photons and a steep dose fall of to the normal tissue, there is a strong
rationale for the use of PRT in the treatment of patients with low-grade glioma. Although
data from large randomized trials are still missing there is increasing evidence from
smaller prospective trials and retrospective analyses that the expected advantages indeed
transform into clinical advantages.
However, in about 20 % of all patients, late contrast-enhancing brain lesions (CEBL)
appear on follow-up MR images 6 - 24 months after treatment. At HIT in Heidelberg and at
OncoRay in Dresden, CEBLs have been observed to occur at very distinct locations in the
brain and relative to the treatment field. Retrospective analysis has elucidated
potential key factors that lead to CEBL occurrence. However, avoidance of CEBLs is hardly
feasible using conventional treatment planning strategies. Model-aided risk avoidance
denotes the use of model-based CEBL risk calculations as an auxiliary tool for clinical
treatment planning: Model-based risk calculations and risk reduction via software-based
optimization help the clinician to minimize risk of CEBL occurrence during treatment
planning.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- previous cerebral irradiation
- contraindication for contrast-enhanced MRI
- neurofibromatosis
- participation in another clinical trial with competing objectives
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiotherapy, University of Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Juergen Debus, Prof. Dr. Dr.
Phone:
+49 6221 56
Phone ext:
8200
Email:
juergen.debus@med.uni-heidelberg.de
Contact backup:
Last name:
Adriane Hommertgen, Dr. med.
Phone:
0622156
Phone ext:
34091
Email:
adriane.hommertgen@med.uni-heidelberg.de
Start date:
November 11, 2023
Completion date:
November 11, 2028
Lead sponsor:
Agency:
University Hospital Heidelberg
Agency class:
Other
Source:
University Hospital Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964569
