High Dose Radiotherapy for Palliation (Hi-D)

NCT07291895 | Not Yet Recruiting

• 1 other identifier: Hi-D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Metastases; Palliative Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Compare changes in local control

  From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24

• Compare changes in OS

  From enrollment to end of study at 24 months or death

Study Arms (2)

High-Dose RT

EXPERIMENTAL

27Gy in 3 fractions with boost

Radiation: Palliative Radiotherapy

Standard Dose Palliative RT

ACTIVE COMPARATOR

24Gy in 3 fractions

Radiation: Palliative Radiotherapy

Interventions

Palliative Radiotherapy RADIATION

standard dose RT

Standard Dose Palliative RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Liu, MD, FRCPC

  BC Cancer - Vancouver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Chang

CONTACT

6048776000; sandy.chang@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CA (1)