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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05964569
Other study ID # RadOnk-Indigo
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 11, 2023
Est. completion date November 11, 2028

Study information

Verified date January 2024
Source University Hospital Heidelberg
Contact Semi Harrabi, MD
Phone +496221 56
Email semi.harrabi@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 11, 2028
Est. primary completion date November 11, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
model-guided optimization of treatment plan
original treatmant plans are optimized based on model-based NTCP
standard treatment plan, no optimization
original treatment plans are not optimized

Locations

Country Name City State
Germany Department of Radiotherapy, University of Heidelberg Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of contrast enhancing brain leasions the cumulative incidence of contrast enhancing brain lesions observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary radiation-induced brain injuries incidence of radiation-induced brain injuries > CTC°II observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary progression-free survival number of surviving patients without tumor progression observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
Secondary overall survival number of surviving patients observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain
Secondary patient reported outcome patient reported outcome according to points on the PRO-CTCAE questionaire, scored 0/1 for absent/present) up to 24 months after completion of radiotherapy
Secondary quality of life QLQ-C30 scores on the QLQ-C30 questionare, scored 0 (absence) to 5 (fully present) up to 24 months after completion of PRT
Secondary quality of life QLQ-BN20 scores on the QLQ-BN20 questionare, scored 0 (absence) to 5 (fully present) up to 24 months after completion of PRT
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