This study investigate if, compared with the literature, an increased dosis of 70 Gy in 7 weeks will improve disease free survival against acceptable toxicity.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease free survival
Secondary outcome
Toxicity
Background summary
this question repeats many previous questions, particularly question c4 and
protocol p. 7-9:
Meningiomas with atypical and malignant features have a high recurrence risk
after neurosurgical resection, despite standard adjuvant radiotherapy (60 Gy).
Study objective
This study investigate if, compared with the literature, an increased dosis of
70 Gy in 7 weeks will improve disease free survival against acceptable
toxicity.
Study design
This is a European multicenter phase II and obesrvational study of adjuvant
postoperative high-dose radiotherapy for atypical and malignant meningioma
(EORTC 22042-26042)
Intervention
High dose radiotherapy (70 Gy)
Study burden and risks
- Extended treatment time from 60 Gy in 6 weeks (10 min per work day) to 70 Gy
in 7 weeks.
- Potentially more side effect; patients will during standard clinical and MRI
follow-up be monitored for radiation-necrosis,
- During each standard out-patient visit, patient will receive the 11-item MMSE
cognitive evaluation.
Avenue E Mounier 83, bte 11
B-1200 Brussel
BE
Avenue E Mounier 83, bte 11
B-1200 Brussel
BE
Listed location countries
Age
Inclusion criteria
summary of protocol page 22:
Adult patients in a fair condition after resection of an intracranial atypical or malignant meningioma.
Exclusion criteria
not D4a
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 |
|---|---|
| CCMO | NL21893.018.08 |
| Other | not relevant |