Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05964569

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Radiotherapy, University of Heidelberg

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Adriane Hommertgen, Dr. med.

CONTACT

[email protected]

0622156 ext. 34091

Juergen Debus, Prof. Dr. Dr.

CONTACT

[email protected]

+49 6221 56 ext. 8200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

model-guided optimization of treatment plan

Other

original treatmant plans are optimized based on model-based NTCP

standard treatment plan, no optimization

Other

original treatment plans are not optimized

Primary outcomes

  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 outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Adriane Lentz-Hommertgen, Phd

CONTACT

[email protected]

+496221 56 ext. 8201

Semi Harrabi, MD

CONTACT

[email protected]

+496221 56 ext. 8201

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study 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

Acronym: INDIGO

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jul 28, 2023
Registry last updated
Jan 5, 2024

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.