Low Dose Versus High Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01135550
• Date of registration: 01/06/2010
• Primary sponsor: The Hospital for Sick Children
• Public title: Low Dose Versus High Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
• Scientific title: 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
• Date of first enrolment: June 2010
• Target sample size: 64
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01135550
• Study type: 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

Countries of recruitment

Canada

Contacts

• Name: Janice Jordaan

• Name: Janice Jordaan

• Name: Ute Bartels, MD
• Affiliation: The Hospital for Sick Children, Toronto Canada

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Headache

Vomiting

Intervention(s)

Drug: High dose dexamethasone

Drug: Low dose dexamethasone

Primary Outcome(s)

Effectiveness of dexamethasone on vomiting [Time Frame: 24-48 hours after first dose of dexamethasone]

Secondary Outcome(s)

Adverse events and side effects [Time Frame: Duration of participation in study]

Headaches [Time Frame: 0-48 hours after first dose of dexamethasone]

Quality of life [Time Frame: Baseline and at end of participation in study]

Secondary ID(s)

1000014713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

C17 Research Network