A Randomized Controlled Multicenter Non-Inferiority Trial of Twice Daily Low Dose Dexamethasone Versus High Dose Dexamethasone for Symptom Control in Children With a Brain Tumour Undergoing Cranial or Craniospinal Radiation
2 Years
18 Years
Both
Vomiting, Headache
Trial Information
A Randomized Controlled Multicenter Non-Inferiority Trial of Twice Daily Low Dose Dexamethasone Versus High Dose Dexamethasone for Symptom Control in Children With a Brain Tumour Undergoing Cranial or Craniospinal Radiation
Dexamethasone is an effective medication to ameliorate radiation induced headache and
vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient
in treating these symptoms. However this experience is not shared from many neuro-oncology
centers of excellence that more commonly use 5 mg/m2/day according to the results of the
trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of
dexamethasone in different dose regimens in symptomatic children while undergoing CNS
radiation will elucidate the appropriate dose.
Inclusion Criteria
Inclusion Criteria for Enrolment:
- Children between 2-18 years of age.
- Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour
after surgical resection.
- Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are
eligible.
- Children who undergo focal or whole brain (± spinal) radiation as part of their brain
tumour treatment.
- Children treated at one of the 16 tertiary care centers in Canada (CPBTC).
- Patients on any anticonvulsive treatment are eligible.
- Patients on concomitant chemotherapy while undergoing radiation are eligible.
- Patients must be ≥ 24 hours steroid-free prior to starting radiation.
- Parents/legal guardians have to have signed and dated an informed consent to allow
study enrolment of their child. (As per institutional guidelines, patients over a
certain age may have signed their own informed consent form.)
- Patients > 8 years of age should assent to study participation.
- Patients less than 10 years of age should have a Lansky Score of >/= 50.
- Patients 10 years of age or older should have a Karnofsky Score of >/= 50. If ECOG
performance scale is used, patient should have a score of 0, 1 or 2.
Exclusion Criteria for Enrolment:
- Children with residual brain tumour lesion > 1.5 cm2 after surgical resection.
- Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to
start of radiation therapy.
Inclusion Criteria for Randomization to a Dexamethasone treatment group:
- Patients must have been enrolled on the Dexamethasone study prior to the start of
radiation therapy.
- Children who develop either symptoms of vomiting (defined as either retching or
vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most
intense headache/day) while undergoing irradiation.
- Patients who are currently undergoing focal or whole brain (± spinal) radiation.
Exclusion Criteria for Randomization to a Dexamethasone treatment group:
- Patients who were not enrolled on Dexamethasone study prior to start of radiation
therapy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Effectiveness of dexamethasone on vomiting
Outcome Description:
The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).
Outcome Time Frame:
24-48 hours after first dose of dexamethasone
Safety Issue:
No
Principal Investigator
Ute Bartels, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Hospital for Sick Children, Toronto Canada
Authority:
Canada: Health Canada
Study ID:
1000014713
NCT ID:
NCT01135550
Start Date:
June 2010
Completion Date:
June 2012
Related Keywords:
- Vomiting
- Headache
- Pediatrics
- Vomiting
- Headache
- Radiation Therapy
- Headache
- Vomiting
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