Clinical trial · Interventional
Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION
NCT01135550CI-TRIAL-00022023terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): premature closure due to lack of accrual
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Headache | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High dose dexamethasone | Drug | Dexamethasone | ALIAS |
| Low dose dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.
- interventionNames
- Drug: High dose dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms.
- interventionNames
- Drug: Low dose dexamethasone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.