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Not yet recruiting NCT07291895

High Dose Radiotherapy for Palliation (Hi-D)

No phase Interventional Metastases Palliative Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Palliative Radiotherapy, Palliative Radiotherapy.
Who it may be relevant to
Registry conditions: Metastases, Palliative Radiotherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Radiation Palliative Radiotherapy
    standard dose RT
  • Radiation Palliative Radiotherapy
    high-dose RT

Primary outcome measures

  • Feasibility of accrual [Time frame: From open to accrual to close to accrual (24 months)]
  • Feasibility of blinding [Time frame: From enrollment to RT completion.]
Secondary outcome measures (2)
  • Compare changes in local control [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • BC Cancer - Vancouver — Vancouver

Identifiers

NCT: NCT07291895 · Hi-D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗