Combined Therapies for Recurrent Brain Cancer
What You Need to Know Before You Apply
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.
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.12345
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.26789
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.210111213
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or hypofractionated radiation therapy (RT) for recurrent brain metastases
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Laser Interstitial Thermal Therapy
- Radiation Therapy
- Steroid Therapy
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Monteris Medical
Lead Sponsor