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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent 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 data supports the effectiveness of the treatment LITT + Radiation for Brain Tumor?

Research shows that hypofractionated stereotactic body radiation therapy (SBRT) is effective for treating various types of metastases, including brain and lung, with high local control rates and relatively low complications. This suggests that similar approaches, like LITT combined with radiation, could be effective for brain tumors. ^{1 2 3 4 5}

Is LITT generally safe for treating brain tumors?

Laser Interstitial Thermal Therapy (LITT) is a minimally invasive treatment for brain tumors, but its safety is not yet well validated in the literature. Some studies have looked at its use for brain tumors, but more research is needed to fully understand its safety profile. ^{6 7 8 9 10}

How is the LITT + Radiation treatment for brain tumors different from other treatments?

LITT + Radiation is unique because it combines minimally invasive laser therapy, which uses heat to destroy tumor tissue, with targeted radiation therapy, offering an alternative to more invasive surgeries and traditional radiation methods. ^{7 10 11 12 13}

Eligibility Criteria

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

My brain MRI shows a tumor 6 cm or smaller.

I am 22 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Helical TomoTherapy for the Focal Hypofractionated Treatment of Limited Brain Metastases in the Initial and Recurrent Setting. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Automatic Intracranial Segmentation: Is the Clinician Still Needed? [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

Current status of stereotactic body radiotherapy for lung cancer. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy (SBRT) for limited hepatic metastases. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Intraclass Correlations of Measured Magnetic Resonance Imaging Volumes of Laser Interstitial Thermal Therapy-Treated High-Grade Gliomas. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Laser interstitial thermotherapy (LITT) for the treatment of tumors of the brain and spine: a brief review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Predictors of Local Control of Brain Metastasis Treated With Laser Interstitial Thermal Therapy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Laser Interstitial Thermal Therapy for Metastatic Melanoma After Failed Radiation Therapy: A Case Series. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Intracranial Metastatic Disease With Laser Interstitial Thermal Therapy. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy as an adjunct therapy in brain tumors: A meta-analysis and comparison with stereotactic radiotherapy. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Laser interstitial thermal therapy (LITT) for intracranial lesions: a single-institutional series, outcomes, and review of the literature. [2022]