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NCT Number: NCT07291895

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

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Key information

Conditions

Metastases Neoplasm Metastasis Neoplasms Neoplastic Processes Palliative Radiotherapy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative radiotherapy

Radiation

standard dose RT

Primary outcomes

  1. 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

  2. Feasibility of blinding

    Time frame: From enrollment to RT completion.

    Trial Assignment Questionnaire administered post-treatment.

Secondary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandy Chang

CONTACT

[email protected]

6048776000

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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