NCT07291895

Brief Summary

Palliative radiation is effective for controlling or preventing symptoms such as pain, bleeding, dyspnea, and cord compression. Recently, studies have shown that additional dose escalation may result in superior local control. The investigators propose a phase II single arm trial to evaluate a novel high-dose radiation regimen, which will be 27 Gray in 3 fractions with dose escalation within the tumour (Hi-D).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
43mo left

Started Mar 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

3.3 years

First QC Date

November 24, 2025

Last Update Submit

August 10, 2026

Conditions

MetastasesPalliative Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Local Control

    to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy

    4 years, with 2 years of accrual and 2 years of follow up

Secondary Outcomes (6)

  • Overall Survival

    4 years, with 2 years of accrual and 2 years of follow up.

  • Progression-Free Survival

    4 years, with 2 years of accrual and 2 years of follow up

  • Side Effects

    4 years, with 2 years of accrual and 2 years of follow up.

  • Local treatment-free survival

    4 years, with 2 years of accrual and 2 years of follow up

  • systemic intensification-free survival

    4 years, with 2 years of accrual and 2 years of follow up

  • +1 more secondary outcomes

Study Arms (1)

High-Dose RT

EXPERIMENTAL

27Gy in 3 fractions with boost

Radiation: Palliative Radiotherapy

Interventions

Palliative RadiotherapyRADIATION

standard dose RT

High-Dose RT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet all of 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
  • Locally advanced or metastatic disease with 1-3 target lesions larger than 5cm in minimum dimension, with no more than 2 target lesions in a single organ; patients can have any number of non-target lesions
  • 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 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

You may not qualify if:

  • Subjects are excluded from the study if any of the following criteria apply:
  • Hematologic malignancy
  • Disease limited to intracranial sites
  • Serious medical co-morbidities precluding radiotherapy
  • Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
  • Pregnant people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Liu, MD, FRCPC

    BC Cancer - Vancouver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Clarke

CONTACT

6048776000aclarke-02@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 18, 2025

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

August 31, 2030

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations

CA(1)