Objectives: • To report treatment outcomes and radiation-induced toxicity from a prospective, multicentre observational cohort of IDHmG patients treated with radiotherapy and chemotherapy,• To intergrate radiotherapeutic dose distributions, imaging…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
• Next intervention free survival during follow-up.
• Freedom of neuropsychological decline during follow-up, defined as a
significant decline in performance in one of the following neuropsychological
tests: Hopkins Verbal Learning test, Trail making test, Controlled Oral Word
Association and Dutch Language Interoperative Protocol.
• Toxicity evaluated with CTCAE - 4.03
Secondary outcome
• MRI changes during follow up.
• Quality of life, as measured by QLQ-C30, BN20 and EQ5D.
• Health economics, as measured by the Productivity Cost Questionnaire and
Medical Consumption Questionaire.
Background summary
Rationale: Standard postoperative treatment of IDH 1/2 mutated glioma, grade 2
and 3 (IDHmG), consists of radiotherapy and chemotherapy. The improving
prognosis of these patients leads towards more emphasis on the long-term
effects of treatment. Specifically radiotherapy has been implicated in the
development of delayed neurocognitive deterioration. The impact of modern
radiotherapy techniques, such as proton beam therapy (PT), and chemotherapy on
general toxicity, late neurocognitive outcomes and imaging changes is currently
unclear.
Study objective
Objectives:
• To report treatment outcomes and radiation-induced toxicity from a
prospective, multicentre observational cohort of IDHmG patients treated with
radiotherapy and chemotherapy,
• To intergrate radiotherapeutic dose distributions, imaging changes and
neuropsychological outcome in IDHmG.
• To evaluate the Dutch selection criteria for proton therapy applied to IDHmG
based on the outcomes collected in this observational study
• To assess the impact of proton and photon therapy on health related quality
of life (QoL) and health-related economics (HR-E) in IDHmG patients.
Study design
Study design: Prospective observational cohort study
Study burden and risks
This project is a multicentre, observational cohort of patients having
undergone radiotherapy and chemotherapy for IDHmG. The protocol closely follows
the local guidelines for clinical follow up. Specific to the study are extra
questionnaires and specific imaging acquired during scheduled MRI*s. Routine
neuropsychological investigation is standard of care in ErasmusMC, but not in
all participating centers. We feel the additional benefit, and burden, of
participation in this study to be negligible.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04304300 |
| CCMO | NL69780.078.19 |