High Dose Radiotherapy for Palliation (Hi-D)

December 5, 2025 updated by: British Columbia Cancer Agency

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Dose RT
27Gy in 3 fractions with boost
Radiation: Palliative Radiotherapy
standard dose RT
Radiation: Palliative Radiotherapy
high-dose RT
Active Comparator: Standard Dose Palliative RT
24Gy in 3 fractions
Radiation: Palliative Radiotherapy
standard dose RT
Radiation: Palliative Radiotherapy
high-dose RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of accrual
Time Frame: From open to accrual to close to accrual (24 months)
≥20 participants enrolled within 24 months from first patient accrued
From open to accrual to close to accrual (24 months)
Feasibility of blinding
Time Frame: From enrollment to RT completion.
Trial Assignment Questionnaire administered post-treatment.
From enrollment to RT completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare changes in local control
Time Frame: From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24
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 Frame: From enrollment to end of study at 24 months or death
Time from randomization to death from any cause. Kaplan-Meier; stratified log-rank.
From enrollment to end of study at 24 months or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Wei Liu, MD, FRCPC, BC Cancer - Vancouver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hi-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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