LITT + Radiation for Brain Tumor

(GCCC 19140 Trial)

Recruiting at 3 trial locations

Overseen By Mark Mishra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Cardiac diseases, Infratentorial tumor, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment plan for recurring brain tumors known as gliomas. It combines two therapies: Laser Interstitial Thermal Therapy (LITT), which uses heat to target tumors, followed by hypo-fractionated radiation therapy, a special type of radiation given in fewer sessions. The trial seeks participants with a history of gliomas that have returned or are growing despite past radiation therapy. Eligible participants should have a tumor no larger than 6 cm on a recent MRI scan and must not have undergone multiple rounds of radiation. As an unphased trial, this study offers a unique opportunity to explore innovative treatment combinations for gliomas.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this treatment regimen is safe for treating recurrent gliomas?

Research has shown that Laser Interstitial Thermal Therapy (LITT) can safely treat brain tumors. Studies have found it successfully targets and treats tumors in about 94.8% of cases. However, some patients experienced side effects such as brain swelling, neurological problems, and bleeding in the brain.

For Hypo-Fractionated Radiation Therapy, research suggests it is generally well-tolerated. This treatment aims to control tumors while protecting healthy brain areas. Studies highlight a good balance between benefits and risks, with effective tumor control and manageable side effects.

Both treatments have shown promise in past patients, but results can vary for each person. It's important to discuss potential risks and benefits with the clinical team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of laser interstitial thermal therapy (LITT) and hypo-fractionated radiation therapy for treating brain tumors because it offers a unique approach compared to traditional methods. Unlike standard treatments like conventional surgery or whole-brain radiation, LITT is a minimally invasive technique that uses laser heat to precisely target and destroy tumor cells. This approach is combined with hypo-fractionated radiation therapy, which delivers a higher dose of radiation over fewer sessions, potentially reducing treatment time and side effects. This combination aims to enhance tumor control while minimizing damage to surrounding healthy brain tissue, offering hope for improved outcomes in brain tumor patients.

What evidence suggests that this trial's treatments could be effective for recurrent gliomas?

Research has shown that Laser Interstitial Thermal Therapy (LITT) is a promising treatment for brain tumors, particularly recurrent gliomas. Studies have found that LITT can safely and effectively target tumors deep in the brain, improving control and possibly extending patients' lives. Meanwhile, Hypo-Fractionated Radiation Therapy, a type of targeted radiation treatment, manages brain tumors with shorter treatment times and fewer side effects. This method helps control the tumor and can maintain the patient's quality of life. In this trial, participants will receive both LITT followed by Hypo-Fractionated Radiation Therapy, which could be a powerful approach to treating recurrent gliomas. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 22 with recurrent WHO Grade II-IV gliomas, who've had prior radiation therapy. They must have a tumor ≤ 6 cm, not undergone re-irradiation, and be in good enough health to undergo surgery. Women of childbearing age need a negative pregnancy test and all participants must agree to use contraception.

Inclusion Criteria

I am 22 years old or older.

My brain MRI shows a tumor 6 cm or smaller.

Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion

Exclusion Criteria

My cancer has spread to the lower part of my brain or its lining.

You cannot have a MRI scan.

Pregnant or breast-feeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laser Interstitial Thermal Therapy (LITT)

Participants undergo Laser Interstitial Thermal Therapy as an alternative to surgical resection for recurrent gliomas

1 week

1 visit (in-person)

Hypofractionated Radiation Therapy

Participants receive hypofractionated radiation therapy, 35Gy/10 fractions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypo-Fractionated Radiation Therapy
• LITT

Trial Overview The study tests using Laser Interstitial Thermal Therapy (LITT) followed by Hypo-fractionated Radiation Therapy on patients with recurring brain tumors called gliomas. It aims to see how effective this combination is for treatment after initial therapies have failed.

How Is the Trial Designed?

Group I: Experimental: LITT with Hypofractionated radiation therapy Experimental Treatment 2 Interventions

Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.

Hypo-Fractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Prostate cancer
• Breast cancer
• Lung cancer
• Gliomas
• Gastrointestinal cancers

Approved in European Union as Hypofractionated Radiotherapy for:

• Prostate cancer
• Breast cancer
• Lung cancer
• Gliomas
• Gastrointestinal cancers

Approved in Canada as Hypofractionated Radiotherapy for:

• Prostate cancer
• Breast cancer
• Lung cancer
• Gliomas
• Gastrointestinal cancers

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Keep Punching Foundation

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

In a study of 13 patients with limited brain metastases, hypofractionated TomoTherapy showed promising outcomes, with a median intracranial progression-free survival of 6.3 months and a local failure rate of 29% at 6 months.

The treatment demonstrated acceptable disease control and survival rates, suggesting that TomoTherapy is a viable option for patients with a limited number of brain metastases, whether in the initial or recurrent setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Helical TomoTherapy for the Focal Hypofractionated Treatment of Limited Brain Metastases in the Initial and Recurrent Setting. Elson, A., Walker, A., Bovi, JA., et al.[2020]

In a study involving 20 patients, two automated segmentation software (iPlan and Smart Segmentation) were evaluated for their effectiveness in planning stereotactic hypofractionated radiotherapy for brain metastases, but the agreement with manual segmentation was found to be poor.

The common segmented volumes between manual and automated methods varied widely (7.71% to 82.54%), indicating that neither software is currently reliable enough for routine use without manual editing in this treatment planning process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Intracranial Segmentation: Is the Clinician Still Needed? Meillan, N., Bibault, JE., Vautier, J., et al.[2019]

Hypofractionated stereotactic body radiotherapy (SBRT) demonstrated a 2-year local control rate of 77.9% and an overall survival rate of 53.7% in a review of 334 patients with pulmonary metastases, indicating its efficacy in managing oligometastatic cancer.

The treatment was associated with a low rate of severe toxicities (4% for SBRT and 2.6% for single fraction stereotactic radiosurgery), suggesting that SBRT is a relatively safe option for patients with limited pulmonary oligometastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. Siva, S., MacManus, M., Ball, D.[2022]

Laser Interstitial Thermotherapy (LITT) is a minimally invasive treatment that has shown promise for various brain tumors, including recurrent glioblastoma, brain metastasis, and radiation necrosis, making it a safe and reliable option for deep-seated tumors.

Despite its growing use, there is a need for more well-designed prospective clinical trials to better define the effectiveness and role of LITT in treating brain and spine lesions, as most current studies lack rigorous design and often combine different types of tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. Chen, C., Lee, I., Tatsui, C., et al.[2021]

In a study of 61 patients with brain metastases treated with Laser Interstitial Thermal Therapy (LITT), incomplete ablation of tumors and the presence of recurrent tumors were significant predictors of local recurrence, with incomplete ablation increasing the risk nearly fivefold.

Patients who received systemic therapy after LITT experienced a longer time to local recurrence, suggesting that combining LITT with systemic treatments may enhance efficacy in controlling tumor progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Local Control of Brain Metastasis Treated With Laser Interstitial Thermal Therapy. Bastos, DCA., Rao, G., Oliva, ICG., et al.[2020]

The study found a high level of agreement among five physicians measuring tumor volumes using Brainlab software, with intraclass correlation coefficients (ICCs) of 0.92 for preoperative, 0.90 for intraoperative, and 0.89 for postoperative volumes, indicating reliable measurements across different observers.

The overall ICC of 0.72 suggests good consistency in volume measurements, which is important for ensuring accurate assessments in laser interstitial thermal therapy (LITT) for brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraclass Correlations of Measured Magnetic Resonance Imaging Volumes of Laser Interstitial Thermal Therapy-Treated High-Grade Gliomas. Noh, T., Griffith, B., Snyder, J., et al.[2020]

MRI-guided Laser Interstitial Thermal Therapy (LITT) is a minimally invasive technique that allows neurosurgeons to effectively treat challenging metastatic brain tumors by using laser-generated heat to destroy abnormal tissue.

This study highlights the growing role of focal therapies like LITT in managing intracranial metastatic disease, showcasing its potential to improve treatment outcomes for patients with difficult-to-treat brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Intracranial Metastatic Disease With Laser Interstitial Thermal Therapy. Salehi, A., Kamath, AA., Leuthardt, EC., et al.[2020]

In a meta-analysis of 25 studies, laser interstitial thermal therapy (LITT) showed a median overall survival of 12.8 months for brain metastasis patients, which is significantly longer than the 9.8 months observed with stereotactic radiosurgery (SRS).

LITT was associated with a 15% reduction in the absolute risk of adverse events compared to SRS, suggesting it may have a safety advantage, although more systematic data and randomized trials are needed to fully establish its role in treating difficult-to-access brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy as an adjunct therapy in brain tumors: A meta-analysis and comparison with stereotactic radiotherapy. de Franca, SA., Tavares, WM., Salinet, ASM., et al.[2022]

Laser interstitial thermal therapy (LITT) is a minimally invasive treatment for brain tumors, showing a pooled incidence of procedure-related adverse events at 30%, with new neurologic deficits and postprocedural edema being the most common, though mostly transient.

The one-year overall survival rates were 43% for high-grade gliomas and 93% for low-grade gliomas, indicating that LITT can be a safe and effective option for certain patients, particularly those with low-grade tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. Alkazemi, M., Lo, YT., Hussein, H., et al.[2023]

Hypofractionated stereotactic body radiation therapy (SBRT) demonstrated a high local control rate of 76% for liver metastases at 10 months, indicating its efficacy in managing these tumors in 69 patients with a median follow-up of 14.5 months.

The treatment was well-tolerated, with no patients experiencing Grade 3 or higher toxicity, highlighting its safety profile for patients with limited hepatic metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy (SBRT) for limited hepatic metastases. Katz, AW., Carey-Sampson, M., Muhs, AG., et al.[2019]

Laser interstitial thermal therapy (LITT) is a safe and effective treatment for metastatic melanoma, showing low complication rates and shorter hospital stays in a case series of 5 patients who had previously failed radiation treatment.

The outcomes from LITT in this study are significantly better compared to traditional treatment options for metastatic melanoma, such as open craniotomy and stereotactic radiosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Interstitial Thermal Therapy for Metastatic Melanoma After Failed Radiation Therapy: A Case Series. Palejwala, AH., O'Connor, KP., Milton, CK., et al.[2021]

Laser interstitial thermal therapy (LITT) is a safe and minimally invasive treatment for brain tumors, showing improved progression-free survival (PFS) and overall survival (OS) in patients with metastatic disease compared to those with primary glial neoplasms.

In a study of 19 patients, median OS after LITT was 25 months for metastatic patients and 24 months for those with primary glial neoplasms, indicating that LITT can be an effective option for extending survival in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy (LITT) for intracranial lesions: a single-institutional series, outcomes, and review of the literature. Dabecco, R., Gigliotti, MJ., Mao, G., et al.[2022]

Stereotactic body radiotherapy (SBRT) offers a promising treatment option for lung and liver cancers, providing a shorter treatment course with fewer clinic visits compared to conventional radiotherapy.

Preliminary results indicate that SBRT achieves over 90% local control of lung tumors with a relatively low rate of complications, making it a potentially effective approach for stage I lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of stereotactic body radiotherapy for lung cancer. Nagata, Y., Matsuo, Y., Takayama, K., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468168/

Hypo-Fractionated Stereotactic Radiosurgery for the ... Improved brain imaging and longer life expectancy of cancer patients have led to an increased prevalence of brain metastases.

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.869572/full

Outcomes of Hypofractionated Stereotactic Radiotherapy ... Conclusions: FSRT is safe and effective in the treatment of brain metastases of any size with excellent local control and toxicity outcomes. Prospective ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1278321825000964

Hypofractionated radiotherapy of central nervous system ... Thus, hypofractionation offers many benefits: higher biological effect and better local control, improved quality of life, preserved immune function and organs ...

4. e-roj.org e-roj.org/journal/view.php?number=1588

Part 1. Brain and head and neck Hypofractionation offers advantages such as shorter treatment times, improved compliance, and under specific conditions, particularly in tumors ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/43/10/4543

Outcomes of 30 Gy/5 Fr Hypofractionated Stereotactic ... We performed a retrospective analysis of the effectiveness and safety of 5-fraction HFSRT for the treatment of BMs under 2 cm diameter.

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2771754

Multi-institutional Analysis of Prognostic Factors and ... The results of this study suggest that hypofractionated stereotactic radiotherapy has a favorable risk-benefit profile and, compared with whole-brain ...