Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05964569

Studienbeginn:
November 2023

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Glioma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Kontakt

Semi Harrabi, MD
Kontakt:
Phone: +496221 56
Phone (ext.): 8201
E-Mail: semi.harrabi@med.uni-heidelberg.de» Kontaktdaten anzeigen

Adriane Lentz-Hommertgen, Phd
Kontakt:
Phone: +496221 56
Phone (ext.): 8201
E-Mail: adriane.lentz-hommertgen@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiotherapy, University of Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Juergen Debus, Prof. Dr. Dr.
Phone: +49 6221 56
Phone (ext.): 8200
E-Mail: juergen.debus@med.uni-heidelberg.de

Adriane Hommertgen, Dr. med.
Phone: 0622156
Phone (ext.): 34091
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. incidence of contrast enhancing brain leasions (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

Secondary outcome:

1. radiation-induced brain injuries (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

2. progression-free survival (Time Frame - observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain):
number of surviving patients without tumor progression

3. overall survival (Time Frame - observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain):
number of surviving patients

4. patient reported outcome (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)

5. quality of life QLQ-C30 (Time Frame - up to 24 months after completion of PRT):
scores on the QLQ-C30 questionare, scored 0 (absence) to 5 (fully present)

6. quality of life QLQ-BN20 (Time Frame - up to 24 months after completion of PRT):
scores on the QLQ-BN20 questionare, scored 0 (absence) to 5 (fully present)

Studien-Arme

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: 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 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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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