Radiotherapy in IDH mutated Glioma: Evaluation of Late outcomes

Conditions: Glioma, IDH mutated, Grade 2 and 3.

Registration Number: NL-OMON28530

Lead Sponsor: ErasmusMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 79

Inclusion Criteria

Age > 18 years
- Histologically confirmed glioma, WHO grade 2 or 3, IDH1/2 mutated
- Indication for standard treatment with radiotherapy and chemotherapy
--- For WHO grade 2 tumors 50.4 Gy (RBE) in 28 fractions.
--- For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions.
- Ability to comply with the protocol, including neuropsychological testing and imaging.
- Ability to understand the requirements of the study and to give written informed con-sent, as determined by the treating physician.
- Written informed consent.

Exclusion Criteria

- Any prior chemotherapy for IDHmG. This includes upfront postoperative chemotherapy.
- Any prior cranial radiotherapy, including but not limited to radiotherapy for IDHmG.
- Prior invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with current PSA of less than or equal to 0.1 ng/mL).
- Extensive white matter disease visible on pre-therapy imaging (Fazekas grade =2)
- Contra-indication for MR imaging (i.e. metal implants, claustrophobia)
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals
- Any other serious medical condition that could interfere with follow-up.
- Severe aphasia or language barrier interfering with assessing endpoints (i.e. comple-tion of questionnaires or neurocognitive performance)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hopkins Verbal Learning Test – delayed recall condition, change from baseline. <br>Toxicity, as evaluated by CTCAE4.03 criteria.

Secondary Outcome Measures

Name	Time	Method
europsychological tests (HVLT-R, TMT A and B, COWA, MOS Cognitive Functioning Scale, DIMA), Next intervention free survival, Progression free survival, Overall survival, Quality of Life questionnaires (EORTC QLQ-C30, BN20, EQ5d-5L), Health-related Economics questionnaires (iMCQ and iPCQ).