Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma

ConditionGlioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center

IDH1/2 mutation

ATRX and/or 1p19q codeletion status

CDKN2A/B codeletion status

Disqualifiers

1. Concurrent participation in another clinical interventional study or participation in a clinical study that requires administration of an investigational drug within 30 days prior to study enrollment.

2. A physical or mental condition of the patient that, in the judgment of the study physician, could endanger the patient, could bias the study results, or could negatively affect the patient's participation in the clinical trial.

3. Known or ongoing abuse of drugs, alcohol, or medications.

4. At the time of tumor recurrence in patients with WHO Grade 2 IDH-mutated CNS gliomas, there is evidence on MRI of malignancy (e.g., marked contrast enhancement indicating Grade 3-4).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proton therapy

    Radiation

    Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE

  • Photon therapy

    Radiation

    Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Photon therapyActive comparator 1 intervention
Group B: Proton therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neurocognition

Composite Z-Score (Neurocognition) based on the cognitive domains assessed 3 years after completion of radiation therapy

Time frame
three years after finishing radiotherapy

Secondary outcomes

1

Neurocognition

Composite Z-Score (neurocognition) based on the assessed cognitive domains (see footnote: study protocol) at 4 weeks and 1, 2, 4, 5, and 6 years after completion of radiation therapy

Time frame
4 weeks and 1, 2, 4, 5, and 6 years after completion of radiation therapy
2

Decline of cognitive domains

A decline of \> 1 SD from the baseline score in one of the cognitive domains studied when compared to the baseline assessment at 4 weeks and 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy

Time frame
At 4 weeks and 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
3

Quality of Life

Quality of Life According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30; Version 3.0; Part A with 28 questions on a Likert scale, 28 to 112 points, Higher score means lower quality of life; Part B with 2 questions on a Likert scale, 2 to 14 points, Lower score means lower quality of life )

Time frame
Pre radiation until 6 years after finishing radiotherapy
4

Quality of Life

Quality of Life According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm 20 (20 questions on a Likert scale; 20 to 80 points; Higher score means lower quality of life)

Time frame
Pre radiation until 6 years after finishing radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

University Hospital Giessen and Marburg

Collaborator