To determine if re-irradiation in 4 fractions is non-inferior to 10 fractions in the primary endpoint of survival after re-irradiation. Secondary objectives are to establish and compare health related quality of life (HRQoL), recurrence patterns,…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is overall survival after re-irradiation.
Secondary outcome
The key secondary endpoint is HRQoL. Other secondary endpoints are recurrence
patterns, progression free survival, toxicity and anti-edema treatment.
Background summary
Re-irradiation is a generally accepted method for salvage treatment in patients
with recurrent glioma. However, no standard radiation regimen has been defined.
Hypofractionation with dose-escalation will reduce patient*s burden while
maintaining the survival benefit.
Study objective
To determine if re-irradiation in 4 fractions is non-inferior to 10 fractions
in the primary endpoint of survival after re-irradiation. Secondary objectives
are to establish and compare health related quality of life (HRQoL), recurrence
patterns, progression free survival, toxicity and anti-edema treatment.
Study design
Phase II, multi-center clincial trial, including a retrospective control group
Intervention
The entire group will receive 4 stereotactic fractions of radiotherapy. The
historical control group received 10 fractions with a similar biologically
equivalent dose.
Study burden and risks
For the patients included in the study, no individual benefits and no known
risks are associated with the tests performed. To reduce patients* burden,
hospital visits are mainly limited to standard follow-up. Most additional
follow-up assessments will be performed by telephone or by self-administered
forms. We use the EQ-5D-5L at baseline and 2, 4 and 6 weeks after start of
radiotherapy and thereafter the QLQ-C15-PAL to assess HRQoL. The questionnaires
could be conducted in less than 10 minutes at home. Additionally, at the same
time points patients will be asked about adverse events, anti-edema treatment
and reminded to complete their HRQoL assessments during a phone call of a few
minutes. Furthermore, technical data, including MRI, CT and radiation treatment
plans, acquired in standard care will be utilized.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Supratentorial recurrent high-grade glioma with contrast enhancement on CE-T1
• The gold standard is histological evidence of a recurrence. When a surgical
procedure to acquire this evidence is not desirable or possible, a recurrence
may be diagnosed by radiological imaging alone, taking the following in
consideration:
o Agreement of the tumor board or a consultant neuro-radiologist that imaging
changes are in keeping with recurrence.
o An interval of no less than 3 months since last (chemo)radiotherapy.
o Utilization of the RANO criteria for tumor progression.
o If needed, additional imaging sequences such as PET and perfusion MRI.
• Unifocal glioma (i.e. lesions clustering around residual surgical cavity)
• Prior course of treatment including radiotherapy with an EQD2 (α/β = 2) of at
least 47Gy
• Age >= 18 years
• Karnofsky Performance Score 60 or above
• Ability of subject to understand character and individual consequences of the
clinical trial (arm1)
• Patients who received re-irradiation for the recurrence of a primary brain
tumor with a treatment schedule of 10x3.5Gy (arm 2).
Exclusion criteria
• Previous re-irradiation or prior radiosurgery or prior treatment with
interstitial radioactive seeds.
• CE-T1 tumor diameter greater than 6cm (~reflecting a spherical tumor of 125cc
).
• Time interval of less than 6 months after prior radiotherapy.
• Time interval of less than 3 weeks after last re-resection (1 week for
biopsy).
• Known carcinoma < 3 years ago (excluding Carcinoma in situ of the cervix,
basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate
treatment interfering with study therapy.
• Women with childbearing potential without adequate contraception.
Design
Recruitment
Medical products/devices used
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 | NL72766.041.20 |