MetastasesNCT07291895
High Dose Radiotherapy for Palliation (Hi-D)
A study testing Palliative Radiotherapy in people with Metastases and Palliative Radiotherapy, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastases, Palliative Radiotherapy
- What is being tested?
- Palliative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2027to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
5.1. Inclusion Criteria
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
5.2. Exclusion Criteria
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Cancer - Vancouver
Vancouver, British Columbia
Sandy Chang, 6048776000, sandy.chang@bccancer.bc.ca
About this study
Official title: A Prospective Study of High Dose Radiotherapy for Palliation: Hi-D
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).
Read the detailed description
This study is being done to see if a new palliative radiotherapy technique can prevent growth or shrink tumors that are bigger than 5cm, for a longer period of time than traditional palliative radiotherapy. The main outcome the investigators are measuring is called "local control"- this refers to how long the treatment is able to stop a cancer from growing. With traditional palliative radiotherapy, radiation is given in smaller doses over multiple, (usually 5 or 10) treatments (called fractions), and the radiation is spread evenly around the tumor. Radiation dose is measured in Gray (Gy). Generally, standard of care/traditional palliative radiotherapy is given as 20 Gy in 5 fractions or 30 Gy in 10 fractions. The new palliative radiotherapy technique the investigators are testing gives a similar radiation dose overall of 27 Gy but gives much higher doses per fraction in only 3 fractions and uses cutting edge technology to concentrate most of the radiation to the center of the tumor. This means that compared to traditional palliative radiotherapy, there is a higher amount of radiation dose that the participant's body and the particularly the center of the tumor is receiving over a shorter period of time. This means a more aggressive treatment for the participants cancer but can also cause an increased risk for side effects. However, because the investigators will concentrate the high doses of radiation only in the center of the tumor, nearby organs do not get too close to the high doses and are spared. The investigators expect that this technique will be as safe as traditional palliative radiotherapy and have a longer duration of effectiveness (longer local control) compared to the older techniques.
- Conditions
- Metastases, Palliative Radiotherapy
- Being tested
- Palliative Radiotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative RadiotherapyRadiation
standard dose RT
Palliative RadiotherapyRadiation
high-dose RT
| Study group | Role | What they receive |
|---|---|---|
| High-Dose RT | Experimental | 27Gy in 3 fractions with boost Receives: Radiation: Palliative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years, with 2 years of accrual and 2 years of follow up
Secondary outcomes (6)
Overall Survival
Time from treatment to death from any cause, or date of last follow-up, whichever occurs first.
Measured: 4 years, with 2 years of accrual and 2 years of follow up.
Progression-Free Survival
Time from treatment to disease progression at any site or death.
Measured: 4 years, with 2 years of accrual and 2 years of follow up
Side Effects
determine side effects from the proposed radiotherapy treatment
Measured: 4 years, with 2 years of accrual and 2 years of follow up.
Local treatment-free survival
Defined as time from treatment to progression beyond next line of local therapy or death from any cause or date of last follow-up, whichever occurs first.
Measured: 4 years, with 2 years of accrual and 2 years of follow up
systemic intensification-free survival
Time from treatment to progression beyond next line of systemic therapy or death from any cause or date of last follow-up, whichever occurs first
Measured: 4 years, with 2 years of accrual and 2 years of follow up
Patient reported Quality of Life
Patient reported quality of life as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Measured: 4 years, with 2 years of accrual and 2 years of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Liu, MD, FRCPC, Principal investigator, BC Cancer - Vancouver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291895
- Sponsor's protocol ID
- Hi-D
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of High Dose Radiotherapy for Palliation: Hi-D
- ClinicalTrials.gov ID
- NCT07291895
- Acronym / sponsor ID
- Hi-D
- Conditions
- Metastases, Palliative Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is being done to see if a new palliative radiotherapy technique can prevent growth or shrink tumors that are bigger than 5cm, for a longer period of time than traditional palliative radiotherapy. The main outcome the investigators are measuring is called "local control"- this refers to how long the treatment is able to stop a cancer from growing. With traditional palliative radiotherapy, radiation is given in smaller doses over multiple, (usually 5 or 10) treatments (called fractions), and the radiation is spread evenly around the tumor. Radiation dose is measured in Gray (Gy). Generally, standard of care/traditional palliative radiotherapy is given as 20 Gy in 5 fractions or 30 Gy in 10 fractions. The new palliative radiotherapy technique the investigators are testing gives a similar radiation dose overall of 27 Gy but gives much higher doses per fraction in only 3 fractions and uses cutting edge technology to concentrate most of the radiation to the center of the tumor. This means that compared to traditional palliative radiotherapy, there is a higher amount of radiation dose that the participant's body and the particularly the center of the tumor is receiving over a shorter period of time. This means a more aggressive treatment for the participants cancer but can also cause an increased risk for side effects. However, because the investigators will concentrate the high doses of radiation only in the center of the tumor, nearby organs do not get too close to the high doses and are spared. The investigators expect that this technique will be as safe as traditional palliative radiotherapy and have a longer duration of effectiveness (longer local control) compared to the older techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Dose RT | Experimental | Radiation: Palliative Radiotherapy27Gy in 3 fractions with boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Radiotherapystandard dose RT | Radiation | High-Dose RT |
| Palliative Radiotherapyhigh-dose RT | Radiation | High-Dose RT |
Primary outcome
Local Control
Time frame: 4 years, with 2 years of accrual and 2 years of follow up
to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy
6 secondary outcomes
Overall Survival
Time frame: 4 years, with 2 years of accrual and 2 years of follow up.
Progression-Free Survival
Time frame: 4 years, with 2 years of accrual and 2 years of follow up
Side Effects
Time frame: 4 years, with 2 years of accrual and 2 years of follow up.
Local treatment-free survival
Time frame: 4 years, with 2 years of accrual and 2 years of follow up
systemic intensification-free survival
Time frame: 4 years, with 2 years of accrual and 2 years of follow up
Patient reported Quality of Life
Time frame: 4 years, with 2 years of accrual and 2 years of follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Related trials for Metastases
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Active, not recruiting
MEST : A School- Based Health Literacy Intervention Trial
Health Literacy, Adolescent Health
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Liu, MD, FRCPC principal investigator
BC Cancer - Vancouver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Radiotherapy in people with Metastases and Palliative Radiotherapy, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Clarke (6048776000, aclarke-02@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: 4 years, with 2 years of accrual and 2 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.