100 Participants Needed

Targeted Radiation Therapy for Brain Cancer

(RAPPLE Trial)

Recruiting at 5 trial locations
SC
Overseen BySandy Chang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunotherapy, targeted therapy, or hormone therapy, you cannot participate in the trial.

What data supports the effectiveness of the treatment RAPPLE for brain cancer?

Research shows that combining targeted therapies with stereotactic radiosurgery (a precise form of radiation therapy) can improve outcomes for brain metastases, which are common in brain cancer. This suggests that targeted radiation treatments like RAPPLE might be effective by leveraging similar principles.12345

Is targeted radiation therapy for brain cancer safe for humans?

Research shows that combining targeted radiation therapy with other treatments like immunotherapy can be safe, but there may be some severe side effects. Experts have developed strategies to reduce these risks, suggesting that while generally safe, careful management is needed.678910

How is the RAPid SimPLE Targeted Radiation Treatment (RAPPLE) different from other brain cancer treatments?

RAPid SimPLE Targeted Radiation Treatment (RAPPLE) is unique because it focuses on increasing the precision of radiation delivery to brain tumors, minimizing damage to surrounding healthy brain tissue, which is a common challenge with traditional radiation therapies.1112131415

Research Team

AN

Alan Nichol, MD

Principal Investigator

BC Cancer Vancouver

Eligibility Criteria

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.

Inclusion Criteria

My doctor thinks I won't live long enough for surgery to help.
My cancer is not related to blood cells.
All my brain tumors can be clearly identified and targeted for treatment.
See 11 more

Exclusion Criteria

Pregnancy
Inability to have a brain MRI
My cancer has spread to the lining of my brain and spinal cord.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single treatment of 8 Gy or five treatments of 4 Gy using volumetric modulated arc therapy to brain metastases

1-5 days
1-5 visits (in-person)

Follow-up

Participants are monitored for survival, control of brain disease, adverse events, and quality of life

1 year

Treatment Details

Interventions

  • RAPid SimPLE Targeted Radiation Treatment
Trial OverviewThe 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.
Participant Groups
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.

RAPid SimPLE Targeted Radiation Treatment is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as RAPid SimPLE Targeted Radiation Treatment for:
  • Brain metastases
🇺🇸
Approved in United States as RAPid SimPLE Targeted Radiation Treatment for:
  • Brain metastases

Find a Clinic Near You

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials
181
Recruited
95,900+

Varian Medical Systems

Industry Sponsor

Trials
63
Recruited
3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Findings from Research

In a study of 173 patients with resected metastatic brain disease, a 3 mm uniform expansion of the stereotactic radiation surgery (SRS) target volume significantly improved coverage of recurrent tumors, potentially enhancing local control rates.
The analysis revealed that the original SRS target volume only overlapped 69.6% of recurrent tumors, but with a 3 mm expansion, this coverage increased to 90%, suggesting that adjusting target volumes could optimize treatment outcomes.
Local recurrence patterns after postoperative stereotactic radiation surgery to resected brain metastases: A quantitative analysis to guide target delineation.Gui, C., Moore, J., Grimm, J., et al.[2019]
Targeted therapies have shown promise in improving survival rates for patients with brain metastases, which are the most common type of brain cancer, particularly when combined with stereotactic radiosurgery.
The review highlights the importance of collaboration among different specialists, including neurosurgeons and oncologists, to optimize treatment strategies for brain metastases from various primary cancers like lung, breast, melanoma, and renal cell carcinoma.
Improving Brain Metastases Outcomes Through Therapeutic Synergy Between Stereotactic Radiosurgery and Targeted Cancer Therapies.Rubino, S., Oliver, DE., Tran, ND., et al.[2022]
The review discusses various treatment options for newly diagnosed and recurrent brain metastases, including whole-brain radiotherapy, radiosurgery, and chemotherapy, highlighting the importance of tailoring treatments to specific patient prognostic subgroups.
Emerging therapies, such as new radiosensitizers and cytotoxic agents, are being explored to improve local control and survival rates while managing the risk of late neurotoxicity associated with these treatments.
Radiotherapy and chemotherapy of brain metastases.Soffietti, R., Costanza, A., Laguzzi, E., et al.[2018]

References

Local recurrence patterns after postoperative stereotactic radiation surgery to resected brain metastases: A quantitative analysis to guide target delineation. [2019]
Improving Brain Metastases Outcomes Through Therapeutic Synergy Between Stereotactic Radiosurgery and Targeted Cancer Therapies. [2022]
Radiotherapy and chemotherapy of brain metastases. [2018]
Cost-effectiveness Analysis of Stereotactic Radiosurgery Alone Versus Stereotactic Radiosurgery with Upfront Whole Brain Radiation Therapy for Brain Metastases. [2018]
Five-Fraction Stereotactic Radiotherapy for Brain Metastases-A Retrospective Analysis. [2023]
Clinical outcomes of biological effective dose-based fractionated stereotactic radiation therapy for metastatic brain tumors from non-small cell lung cancer. [2022]
Safety and Tolerability of Metastasis-Directed Radiation Therapy in the Era of Evolving Systemic, Immune, and Targeted Therapies. [2022]
Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium. [2023]
Toxicity of concurrent stereotactic radiotherapy and targeted therapy or immunotherapy: A systematic review. [2022]
Five-fraction stereotactic radiosurgery (SRS) for single inoperable high-risk non-small cell lung cancer (NSCLC) brain metastases. [2022]
Targeted radiotherapy of brain tumours. [2022]
Physical and biological targeting of radiotherapy. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Single-Isocenter Multitarget Stereotactic Radiosurgery Is Safe and Effective in the Treatment of Multiple Brain Metastases. [2022]
Guidelines for Multiple Brain Metastases Radiosurgery. [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
Magnetic resonance imaging changes after stereotactic radiation therapy for childhood low grade astrocytoma. [2010]