Medium and long term outcomes after modern radiotherapy for IDH mutated glioma

Recruiting

Conditions: Glioma
IDH mutated. Glioma
low grade (WHO 2) and anaplastic (WHO 3)
10029211

Registration Number: NL-OMON52769

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 79

Inclusion Criteria

- Age > 18 years
- Resection (any grade) or biopsy of one of the following: glioma, WHO grade 2
or 3, IDH mutated
- Indication and fit for standard treatment with radiotherapy and chemotherapy
o For WHO grade 2 tumors 50.4 Gy (RBE) in 28 fractions.
o For WHO grade 3 tumors 59.4 Gy (RBE) in 33 fractions.
- Ability to comply with the protocol, including neuropsychological testing and
imaging, as judged by the local investigator.
- Ability to understand the requirements of the study and to give written
informed consent.
- Written informed consent.

Exclusion Criteria

- Any prior cranial radiotherapy.
- Prior or second invasive malignancy, except non-melanoma skin cancer,
completely resected cervical or prostate cancer (with 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.
- Aphasia or language barrier interfering with endpoints and questionnaires
(i.e. assessment of QoL, neurocognitive performance)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br>• Next intervention free survival during follow-up.<br /><br>• Freedom of neuropsychological decline during follow-up, defined as a<br /><br>significant decline in performance in one of the following neuropsychological<br /><br>tests: Hopkins Verbal Learning test, Trail making test, Controlled Oral Word<br /><br>Association and Dutch Language Interoperative Protocol.<br /><br>• Toxicity evaluated with CTCAE - 4.03</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• MRI changes during follow up.<br /><br>• Quality of life, as measured by QLQ-C30, BN20 and EQ5D.<br /><br>• Health economics, as measured by the Productivity Cost Questionnaire and<br /><br>Medical Consumption Questionaire.</p><br>