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

NCT05964569 | Recruiting Phase 2

• 1 other identifier: RadOnk-Indigo
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Low Grade Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• radiation-induced brain injuries

  observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain

• progression-free survival

  observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain

• overall survival

  observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain

• patient reported outcome

  up to 24 months after completion of radiotherapy

• quality of life QLQ-C30

  up to 24 months after completion of PRT

Study Arms (2)

Standard treatment plan

ACTIVE COMPARATOR

Model-based NTCP is calculated after plan approval, however, no further adjustments are to be made to the approved treatment plan

Other: standard treatment plan, no optimization

Optimized treatment plan

EXPERIMENTAL

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.

Other: model-guided optimization of treatment plan

Interventions

model-guided optimization of treatment plan OTHER

original treatmant plans are optimized based on model-based NTCP

Optimized treatment plan

standard treatment plan, no optimization OTHER

original treatment plans are not optimized

Standard treatment plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous cerebral irradiation
• contraindication for contrast-enhanced MRI
• neurofibromatosis
• participation in another clinical trial with competing objectives

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Radiotherapy, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Central Study Contacts

Semi Harrabi, MD

CONTACT

+496221 56; semi.harrabi@med.uni-heidelberg.de

Adriane Lentz-Hommertgen, Phd

CONTACT

+496221 56; adriane.lentz-hommertgen@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head

Model Details: randomized, observer blind two arm (active control), parallel group

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: November 11, 2023
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2028
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)