Recruiting
Phase 2

Targeted Radiation

Sponsor:

British Columbia Cancer Agency

Code:

NCT05050929

Conditions

Brain Metastases, Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Targeting All Brain Metastases

Study Details

Brief summary:

The aim of the study is to show that rapid, simple targeted radiotherapy to brain metastases with 8 Gy / 1 is non-inferior to 20 Gy / 5 in terms of overall survival for patients with poor prognosis.

Conditions

Brain Metastases, Adult

Study ID

NCT05050929

Start date

Jul 1, 2022

Status verified date

Apr, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in this study:

  • Age ≥ 18
  • Pathological diagnosis of a non-hematopoietic malignancy
  • Brain metastases of any size
  • Any number of untreated or progressing, previously treated brain metastases that can all be contoured and targeted
  • Presence of extracranial disease
  • Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https://brainmetgpa.com/) or Graded Prognostic Assessment ≤ 2.0 (Appendix I)
  • Able to complete the EuroQOL (EQ-5D-5L) questionnaire
  • Willing and able to have regular imaging follow up
  • Feasible to start protocol treatment within 14 days of participant enrolment
  • Karnofsky Performance Score (KPS) ≥ 50

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

  • Inability to have a brain MRI
  • WBRT less than 3 months prior to randomization
  • Disseminated leptomeningeal carcinomatosis (limited pachymeningeal disease is permitted)
  • Multiple sclerosis
  • Neurologically declining despite corticosteroids
  • Appropriate for surgery or stereotactic radiosurgery
  • Germ cell and primary brain tumours
  • Systemic lupus erythematosis, scleroderma, or other connective tissue disorders not in remission
  • Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
  • Pregnancy
  • Potentially fertile men or women of childbearing potential who are unwilling to employ highly effective contraception

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain Metastases

Five treatments of 4 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.

experimental: 8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain Metastases

A single treatment of 8 Gy will be delivered using volumetric modulated arc therapy on a conventional linear accelerator in a conventional head shell without the use of stereotactic radiosurgery technique.

Interventions

Targeting All Brain Metastases

Volumetric Modulated Arc Therapy

Primary outcome measure

  • Survival Time [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sandy Chang

604-877-6000sandy.chang@bccancer.bc.ca

Locations

BC Cancer - Abbotsford

Recruiting

Abbotsford, British Columbia, Canada

Contacts

Fred Hsu, BSc MD FRCPC

6048514710

BC Cancer - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y5L3

Contacts

Benjamin Mou, MD FRCPC DABR

250-712-3900Benjamin.Mou@bccancer.bc.ca

BC Cancer - Prince George

Recruiting

Prince George, British Columbia, Canada, V2M7E9

Contacts

Robert Olson, MD MSc FRCPC

25064573000rolson2@bccancer.bc.ca

BC Cancer - Surrey

Recruiting

Surrey, British Columbia, Canada

Contacts

Sarah Baker, MD

604.930.2098

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Sandy Chang

604-675-4100sandy.chang@bccancer.bc.ca

Principal Investigator:

Shilo Lefresne, MD

BC Cancer - Victoria

Recruiting

Victoria, British Columbia, Canada

Contacts

Isabelle Vallieres, MD MSc FRCPC

2505195577isabelle.vallieres@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Apr 17, 2025

Last verified

Apr, 2025

Keywords

  • radiotherapy
  • randomized clinical trial
  • phase II
  • non-inferiority
  • overall survival

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2025-04-17.