High Dose Radiotherapy for Palliation (Hi-D)

NCT ID: NCT07291895

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Metastases Palliative Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High-Dose RT

27Gy in 3 fractions with boost

Group Type EXPERIMENTAL

Palliative Radiotherapy

Intervention Type RADIATION

high-dose RT

Standard Dose Palliative RT

24Gy in 3 fractions

Group Type ACTIVE_COMPARATOR

Palliative Radiotherapy

Intervention Type RADIATION

standard dose RT

Interventions

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Palliative Radiotherapy

standard dose RT

Intervention Type RADIATION

Palliative Radiotherapy

high-dose RT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Cancer Agency

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Liu, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

BC Cancer - Vancouver

Locations

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BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Sandy Chang

Role: CONTACT

Phone: 6048776000

Email: [email protected]

Facility Contacts

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Sandy Chang

Role: primary

Other Identifiers

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Hi-D

Identifier Type: -

Identifier Source: org_study_id