Department of Radiotherapy, University of Heidelberg
Heidelberg, 69120, Germany
Location status: Recruiting
Location contact
Adriane Hommertgen, Dr. med.
CONTACT
0622156 ext. 34091
Juergen Debus, Prof. Dr. Dr.
CONTACT
+49 6221 56 ext. 8200
NCT Number: NCT05964569
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Heidelberg, 69120, Germany
Location status: Recruiting
Adriane Hommertgen, Dr. med.
CONTACT
0622156 ext. 34091
Juergen Debus, Prof. Dr. Dr.
CONTACT
+49 6221 56 ext. 8200
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
original treatmant plans are optimized based on model-based NTCP
original treatment plans are not optimized
Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
the cumulative incidence of contrast enhancing brain lesions
Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
incidence of radiation-induced brain injuries > CTC°II
Time frame: observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain
number of surviving patients without tumor progression
Time frame: observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain
number of surviving patients
Time frame: up to 24 months after completion of radiotherapy
patient reported outcome according to points on the PRO-CTCAE questionaire, scored 0/1 for absent/present)
Time frame: up to 24 months after completion of PRT
scores on the QLQ-C30 questionare, scored 0 (absence) to 5 (fully present)
Time frame: up to 24 months after completion of PRT
scores on the QLQ-BN20 questionare, scored 0 (absence) to 5 (fully present)
Contact information is provided by the study sponsor or research team.
Adriane Lentz-Hommertgen, Phd
CONTACT
+496221 56 ext. 8201
Semi Harrabi, MD
CONTACT
+496221 56 ext. 8201
University Hospital Heidelberg
Other
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
Acronym: INDIGO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04166409
Low Grade Astrocytoma, Low Grade Glioma
Birmingham, Alabama, United States
View Trial DetailsNCT06712875
Glioma, High Grade Glioma
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05538130
Advanced or Metastatic Solid Tumors, Brain Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06132685
Brain Diseases, Brain Neoplasms
Atlanta, Georgia, United States
View Trial Details