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Clinical Trial NCT07291895 for Metastases, Palliative Radiotherapy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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High Dose Radiotherapy for Palliation (Hi-D) 20 Dose Escalation

Not yet recruiting
Clinical Trial NCT07291895 is an interventional study for Metastases, Palliative Radiotherapy and is currently not yet recruiting. Enrollment is planned to begin on January 1, 2026 and continue until the study accrues 20 participants. Led by British Columbia Cancer Agency, this study is expected to complete by August 31, 2029. The latest data from ClinicalTrials.gov was last updated on December 18, 2025.
Brief Summary
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

Official Title

A Prospective Single-blinded Randomized Study of High Dose Radiotherapy for Palliation: Hi-D

Conditions
MetastasesPalliative Radiotherapy
Other Study IDs
  • Hi-D
NCT ID Number
NCT07291895
Start Date (Actual)
2026-01-01
Last Update Posted
2025-12-18
Completion Date (Estimated)
2029-08-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHigh-Dose RT
27Gy in 3 fractions with boost
Palliative Radiotherapy
high-dose RT
Active ComparatorStandard Dose Palliative RT
24Gy in 3 fractions
Palliative Radiotherapy
standard dose RT
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Feasibility of accrual
≥20 participants enrolled within 24 months from first patient accrued
From open to accrual to close to accrual (24 months)
Feasibility of blinding
Trial Assignment Questionnaire administered post-treatment.
From enrollment to RT completion.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Compare changes in local control
Kaplan-Meier curves; stratified log-rank test
From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24
Compare changes in OS
Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank.
From enrollment to end of study at 24 months or death
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Subjects must meet all the following criteria to be eligible for participation in this study:

  • Age 18 or older.

  • Able to provide informed consent

  • Patient has histologically confirmed solid tumour malignancy

  • ECOG performance status 0 - 2

  • Life Expectancy > 6 months

  • 1-5 target lesions larger than 5cm

  • A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment

  • Not suitable for or declined curative-intent treatment

  • Subject has had a CT neck, chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment

  • MRI spine for patients receiving RT to vertebral or paraspinal metastases

  • Patient is judged able to:

    • Maintain a stable position during therapy
    • Tolerate immobilization device(s) that may be required to deliver radiation safely

  • - Hematologic malignancy.
  • Disease limited to intracranial sites
  • Serious medical co-morbidities precluding radiotherapy
  • Bone metastases with no soft tissue component
  • Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
  • Pregnant women
British Columbia Cancer Agency logoBritish Columbia Cancer Agency
Study Central Contact
Contact: Sandy Chang, 6048776000, [email protected]
1 Study Locations in 1 Countries

British Columbia

BC Cancer - Vancouver, Vancouver, British Columbia, Canada
Sandy Chang, Contact, 6048776000, [email protected]