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

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ClinicalTrials.gov Identifier: NCT05964569
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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

Condition or disease Intervention/treatment Phase
Low Grade Glioma Other: model-guided optimization of treatment plan Other: standard treatment plan, no optimization Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, observer blind two arm (active control), parallel group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 11, 2023
Estimated Primary Completion Date : November 11, 2026
Estimated Study Completion Date : November 11, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Other: standard treatment plan, no optimization
original treatment plans are not optimized
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:

  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
original treatmant plans are optimized based on model-based NTCP


Outcome Measures
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Primary Outcome Measures :
  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 Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964569


Contacts
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Contact: Semi Harrabi, MD +496221 56 ext 8201 semi.harrabi@med.uni-heidelberg.de
Contact: Adriane Lentz-Hommertgen, Phd +496221 56 ext 8201 adriane.lentz-hommertgen@med.uni-heidelberg.de

Locations
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Germany
Department of Radiotherapy, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Juergen Debus, Prof. Dr. Dr.    +49 6221 56 ext 8200    juergen.debus@med.uni-heidelberg.de   
Contact: Adriane Hommertgen, Dr. med.    0622156 ext 34091    adriane.hommertgen@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
  Study Documents (Full-Text)

Documents provided by Juergen Debus, University Hospital Heidelberg:
Study Protocol  [PDF] October 21, 2022

More Information
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Responsible Party: Juergen Debus, Department Head, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT05964569    
Other Study ID Numbers: RadOnk-Indigo
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue