← Back to Search

Radiation Therapy

Targeted Radiation Therapy for Brain Cancer (RAPPLE Trial)

Phase 2

Recruiting

Led By Alan Nichol, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Disseminated leptomeningeal disease

History of epilepsy or seizures, and not currently taking anti-epileptic medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, more targeted form of radiation therapy against the standard form of radiation therapy to see if it is just as effective in treating brain metastases.

Who is the study for?

This trial is for adults with non-blood related cancers that have spread to the brain. Participants should have multiple brain tumors that can be targeted, a life expectancy not suitable for surgery or precise radiotherapy, and some active cancer outside the brain. They must also be able to complete questionnaires, follow up with imaging tests, start treatment within two weeks of joining, and have a performance score indicating they are still somewhat active.

What is being tested?

The study is testing if one session of targeted radiation (8 Gy) is as effective as five sessions (20 Gy total) in extending overall survival for patients with poor prognosis due to brain metastases from other cancers. The goal is to determine whether this simpler and quicker treatment approach works just as well.

What are the potential side effects?

While specific side effects aren't listed here, radiation therapy can generally cause fatigue, headaches, hair loss at the treated site, nausea, and may temporarily worsen neurological symptoms related to brain tumors.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to the lining of my brain and spinal cord.

Select...

I have had epilepsy or seizures but am not on seizure medication now.

Select...

I have not had whole brain radiotherapy in the last 6 months.

Select...

I am scheduled for immunotherapy, targeted therapy, or hormone therapy after radiation.

Select...

My neurological condition is worsening even with steroid treatment.

Select...

I have not had brain surgery in the last 3 months.

Select...

I have multiple sclerosis.

Select...

I need surgery to reduce pressure inside my skull.

Select...

My lupus, scleroderma, or similar condition is not in remission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survival Time

Secondary study objectives

Adverse Events

Control of brain disease

Control of treated brain metastases

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 8 Gy in 1 Fraction Volumetric Modulated Arc Therapy to Brain MetastasesExperimental Treatment1 Intervention

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.

Group II: 20 Gy in 5 Fractions Volumetric Modulated Arc Therapy to Brain MetastasesActive Control1 Intervention

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.

0 / 9Eligibility criteria met