261 Participants Needed

Combined Therapies for Recurrent Brain Cancer

Recruiting at 8 trial locations
LM
CS
Overseen ByChrista Seligman
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Randomized, post-market multi-center study investigating the efficacy of two sets of treatment algorithms in brain metastases (BM) patients at the time of first intervention for radiographic progression after stereotactic radiosurgery (SRS), with or without surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used bevacizumab within 4 weeks of starting the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of this treatment for recurrent brain cancer?

Research shows that radiotherapy, including stereotactic radiosurgery and reirradiation, can improve survival and quality of life for patients with recurrent brain metastases, with minimal side effects. These treatments are effective in controlling local brain disease and are considered safe options for managing relapsing brain conditions.12345

Is the combined therapy for recurrent brain cancer generally safe for humans?

Image-guided radiation therapy (IGRT) and intensity-modulated radiotherapy (IMRT) are generally considered safe, with some risk of side effects like gastrointestinal and genitourinary issues. The safety of these therapies has been a focus of research, and they are commonly used in clinical practice.36789

How is the treatment of radiation therapy unique for recurrent brain cancer?

Radiation therapy for recurrent brain cancer is unique because it uses advanced techniques like stereotactic radiotherapy (SRT) and intensity-modulated radiation therapy (IMRT) to precisely target tumors, minimizing damage to healthy brain tissue. This approach allows for a second course of radiation, which is not standard, offering a potential option for patients with recurrent tumors.310111213

Eligibility Criteria

This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

I am 18 years old or older.
I've been stable for 3 days on a low steroid dose.
I had my initial SRS treatment for the target lesion over 3 months ago.
See 10 more

Exclusion Criteria

My cancer outside the brain is quickly getting worse.
I do not have any serious infections or other major health issues.
Patients unable to comply with study requirements
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or hypofractionated radiation therapy (RT) for recurrent brain metastases

3 months
Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

24 months
Post-op visit, 1 month visit, and subsequent follow-up visits until study exit or 24 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • Laser Interstitial Thermal Therapy
  • Radiation Therapy
  • Steroid Therapy
Trial OverviewThe REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Recurrent TumorExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Group II: Radiation NecrosisExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇺🇸
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

Monteris Medical

Lead Sponsor

Trials
10
Recruited
1,600+

Findings from Research

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]
Stereotactic radiosurgery is a commonly used and effective treatment for recurrent or progressive brain metastases, showing good results in local brain control and patient survival based on various clinical studies.
This treatment is considered relatively safe, with a low incidence of brain toxicity side effects, but further well-designed randomized studies are needed to refine patient selection and treatment guidelines.
Salvage stereotactic radiosurgery for brain metastases.Klironomos, G., Bernstein, M.[2013]
Salvage stereotactic radiotherapy (SRT) using CyberKnife for recurrent gliomas showed an acceptable safety profile, with only 11.4% of patients experiencing significant toxicity, specifically radiation-induced brain necrosis.
The treatment resulted in a median overall survival of 9 months and a progression-free survival of 3 months, indicating that SRT can be a viable option for patients with recurrent gliomas after initial treatment.
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife.Adachi, K., Hayashi, K., Kagawa, N., et al.[2019]

References

Radiotherapy and chemotherapy of brain metastases. [2018]
Salvage stereotactic radiosurgery for brain metastases. [2013]
Feasibility of Salvage Re-irradiation With Stereotactic Radiotherapy for Recurrent Glioma Using CyberKnife. [2019]
Improving radiotherapy for brain tumors. [2005]
Reirradiation for progressive brain metastases. [2022]
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]
Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial. [2021]
A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The evolving role of reirradiation in the management of recurrent brain tumors. [2023]
Repeated stereotactic radiosurgery for recurrent brain metastases: An effective strategy to control intracranial oligometastatic disease. [2020]
Efficacy of stereotactic radiotherapy as salvage treatment for recurrent malignant gliomas. [2018]
Salvage Radiation Therapy for Patients With Relapsing Glioblastoma Multiforme and the Role of Slow Fractionation. [2022]