60 Participants Needed

Radiation Therapy for Brain Cancer

(GK-LIVE Trial)

AT
HC
Overseen ByHanbo Chan, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sunnybrook Health Sciences Centre
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach for treating large brain tumors using a combination of two radiation machines. Patients will begin with four treatments using a linear accelerator, take a short break, and then receive a final treatment with a Gamma Knife. This method aims to improve tumor control and reduce side effects, such as swelling in healthy brain tissue. Individuals with up to two large brain lesions or up to ten smaller brain tumors that have not responded to treatment might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic cancer chemotherapy or immunotherapy at least 2 days before and after each radiation treatment session. Other medications are not specifically mentioned, so you should discuss your current medications with the study doctors.

What prior data suggests that this combined Gamma Knife/Linac radiosurgery is safe for treating large brain tumors?

Research has shown that both the Gamma Knife and linear accelerator are safe and effective for treating brain tumors. Studies have found that they control tumors in over 90% of cases, effectively keeping tumors in check. Importantly, they also help protect healthy brain tissue.

The Gamma Knife and linear accelerator are generally well-tolerated regarding side effects. While side effects like radiation necrosis can occur, they are uncommon. This condition involves swelling and damage to healthy tissue, but the precision of these machines helps reduce this risk.

Using both machines together aims to improve results by targeting tumors more precisely. This approach may lead to better tumor control and fewer side effects compared to using the linear accelerator alone.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the combined Gamma Knife/Linac radiosurgery for brain cancer because it offers a unique approach to targeting tumors. Unlike traditional brain cancer treatments, such as whole-brain radiation therapy or conventional surgery, this treatment uses highly focused beams of radiation to precisely target cancer cells, sparing surrounding healthy tissue. This precision can potentially lead to fewer side effects and improved quality of life for patients. Additionally, the combination of Gamma Knife and Linac allows for enhanced flexibility and adaptability in treatment planning, which may improve overall outcomes.

What evidence suggests that this combined Gamma Knife/Linac radiosurgery might be an effective treatment for brain cancer?

Research has shown that using both Gamma Knife and linear accelerator radiosurgery for brain tumors can be very effective. In this trial, participants will receive Combined Gamma Knife/Linac Radiosurgery. Studies have found that staged Gamma Knife radiosurgery for large brain tumors controls the tumor in 83% of cases after 12 months. The Gamma Knife delivers precise radiation, protecting healthy brain tissue. The linear accelerator, when used in multiple treatments, effectively manages larger tumors. Combining these methods may offer better tumor control and fewer side effects than using just the linear accelerator. This approach aims to improve results by targeting tumors more precisely while protecting healthy tissue.678910

Are You a Good Fit for This Trial?

This trial is for individuals with large brain tumors or metastases who may have neurological impairments. It's not suitable for those who've had sex reassignment surgery or other conditions that could interfere with the treatment.

Inclusion Criteria

Expected survival greater than 3 months
Patients suitable for both GK and Linac based treatment
I have up to two large brain tumors.
See 4 more

Exclusion Criteria

Patient with absolute contraindications for MRI
Pregnant or lactating patient
Inability or unwillingness to undergo informed consent or post-treatment follow-up
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Combined Gamma Knife/Linac Radiosurgery
Trial Overview The study tests a new approach combining linear accelerator radiation over 4 days, a break, then precise Gamma Knife therapy. This aims to improve tumor control and reduce side effects by targeting remaining tumor more accurately.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Citations

Study Details | NCT07162246 | Combined Gamma Knife/ ...The investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to ...
Combined Gamma Knife/Linac Radiosurgery for Large Brain ...This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities ...
Transforming Brain Tumor Care: The Global Impact of ...Our study underscores the clinical efficacy of SRS for brain metastases, achieving a median radiographic control rate of 82%, a median OS of 11 ...
Staged Gamma Knife radiosurgery for large brain metastasesStaged Gamma Knife radiosurgery for large brain metastases resulted in an 83 % probability of local control at 12 months. •. Local control was further increased ...
Response of treatment-naive brain metastases to ...Our results demonstrate that brain metastases ≤3 cm are not uniformly responsive to SRS and suggest that prospective studies to evaluate the effect of SRS alone
Study Details | NCT07162246 | Combined Gamma Knife/ ...This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or ...
Assessing the long-term safety and efficacy of gamma knife ...Tumor control rates were 93% (95% CI 91-94%) and 94% (95% CI 91-97%) for GK and LINAC, respectively. Both GK (OR 0.06, 95% CI 0.02-0.13) and LINAC (OR 0.47, 95% ...
Stereotactic radiosurgery in the treatment of brain metastasesGamma Knife and Linac based radiosurgery provide consistent results with a reproducible local tumor control in both single and multiple brain metastases.
Analysis of linear accelerator-based fractionated ...Results: Results as of December 2023 showed median intracranial progression-free survival (iPFS) at 12.4 months, with median overall survival (OS) not reached ...
Tumor Control Probability of Radiosurgery and ...We herein report on the TCP analysis for brain metastases treated with SRS and fSRS, with the. Redmond et al. International Journal of Radiation Oncology ...
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