High Dose Radiotherapy for Palliation (Hi-D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
The goal of this clinical trial is to evaluate the feasibility of single-blind randomization between two palliative regimens - standard 24 Gray in 3 fractions vs a high-dose (Hi-D) 27 Gray in 3 fractions with dose escalation within the tumor in participants with bulky metastatic cancer.
The main question
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older.
Able to provide informed consent
Patient has histologically confirmed solid tumour malignancy
ECOG performance status 0 - 2
Disqualifiers
- Hematologic malignancy.
Disease limited to intracranial sites
Serious medical co-morbidities precluding radiotherapy
Bone metastases with no soft tissue component
Trial design
Design model
Parallel
Treatments tested in this trial
Palliative Radiotherapy
Radiationstandard dose RT
Palliative Radiotherapy
Radiationhigh-dose RT
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: High-Dose RTExperimental treatment 1 intervention
Group B: Standard Dose Palliative RTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of accrual
≥20 participants enrolled within 24 months from first patient accrued
Time frame
From open to accrual to close to accrual (24 months)2
Feasibility of blinding
Trial Assignment Questionnaire administered post-treatment.
Time frame
From enrollment to RT completion.Secondary outcomes
1
Compare changes in local control
Kaplan-Meier curves; stratified log-rank test
Time frame
From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,242
Compare changes in OS
Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank.
Time frame
From enrollment to end of study at 24 months or deathSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: