RAPid SimPLE Targeted Radiation Treatment for Brain Metastases

Last updated: April 15, 2025
Sponsor: British Columbia Cancer Agency
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Treatment

Targeting All Brain Metastases

Clinical Study ID

NCT05050929
H21-01343
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 canall be contoured and targeted

  • Presence of extracranial disease

  • Diagnosis-Specific Graded Prognostic Assessment ≤ 2.0. (https://brainmetgpa.com/) orGraded 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

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 ispermitted)

  • 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 notin remission

  • Any other serious intercurrent illness or medical condition judged by the localinvestigator to compromise the participant's safety, preclude safe administration ofthe planned protocol treatment, or prevent the participant from being managedaccording to the protocol guidelines

  • Pregnancy

  • Potentially fertile men or women of childbearing potential who are unwilling toemploy highly effective contraception

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Targeting All Brain Metastases
Phase: 2
Study Start date:
July 01, 2022
Estimated Completion Date:
December 30, 2027

Study Description

Hypothesis For selected patients with limited life expectancy, a single targeted fraction of 8 Gy / 1 to brain metastases will provide equivalent survival as targeted radiotherapy with 20 Gy / 5 to brain metastases.

Justification The QUARTZ study randomized patients with brain metastases and poor prognosis between 20 Gy / 5 whole brain radiotherapy (WBRT) and best supportive care. The median survival in both arms of the study was 9 weeks. The quality of life in both arm was also the same. It is known that WBRT significantly diminishes quality of life. The investigators interpretation of the QUARTZ trial is that the unchecked growth of brain metastases in the best supportive care arm diminishes quality of life as much as WBRT. To control brain metastases without giving WBRT, targeted treatment with 20 Gy / 5 to the metastases alone is standard care at BC Cancer. Numerous randomized trials have compared the efficacy of 20-30 Gy / 5-10 fractions and 8 Gy / 1 for palliative treatment of pain from bone metastases. In addition, there is a randomized trial showing that 20 Gy / 5 and 8 Gy /1 are equally effective for the treatment of symptoms from spinal cord compression. This study will test the use of this shorter, one-visit treatment schedule against the standard 5-visit treatment schedule for patients with brain metastases.

Research Design Randomized Phase II Non-Inferiority Study. The estimated median survival for this cohort, based upon a prior cohort study from 2012-2016 at BC Cancer is 3 months (13 weeks). The investigators would regard a study median survival of less than the 9-week median survival observed in the QUARTZ trial as unacceptable. Hence, the hazard ratio for the experimental arm and the control arm is: 13 weeks / 9 weeks = 1.44. With one-sided Type I error set at alpha = 0.2 and power = 0.8, the investigators calculated a theoretical sample size of 86 patients. Based on prior experience with clinical trials for patients with brain metastases, a 15% risk of drop-out and loss to follow up is expected. Hence the final sample size will be 100 patients. Stratification by the diagnosis-specific graded prognostic assessment (DS-GPA) ranges of 0.0 - 1.0 and 1.5 - 2.0 and lung cancer versus other histologies will help to ensure baseline characteristics that predict for equal survival are equally distributed in both arms of the study.

Statistical Analysis The primary endpoint is overall survival. The study will be considered to be a positive phase II non-inferiority study if the median survival in the experimental arm is within 4 weeks of the median survival in the standard arm.

Connect with a study center

  • BC Cancer - Abbotsford

    Abbotsford, British Columbia
    Canada

    Active - Recruiting

  • BC Cancer - Kelowna

    Kelowna, British Columbia V1Y5L3
    Canada

    Active - Recruiting

  • BC Cancer - Prince George

    Prince George, British Columbia V2M7E9
    Canada

    Active - Recruiting

  • BC Cancer - Surrey

    Surrey, British Columbia
    Canada

    Active - Recruiting

  • BC Cancer - Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BC Cancer - Victoria

    Victoria, British Columbia
    Canada

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.