Lattice Radiotherapy for Cancer

Overseen By Andrew Frankart, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Cincinnati

Must not be taking: Cytotoxic chemotherapy, Radiosensitizing agents

Disqualifiers: Hematologic malignancies, CNS malignancies, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 2 weeks

37 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking cytotoxic chemotherapy or known radiosensitizing agents (medications that make cancer cells more sensitive to radiation) within 5 days before or after lattice therapy.

What data supports the effectiveness of the treatment Lattice Radiotherapy for Cancer?

Lattice Radiotherapy (LRT) has shown promising results in treating large tumors, such as in a case where a patient with advanced lung cancer experienced significant improvement and no evidence of disease after treatment. Additionally, over 30 patients with various cancers have been treated with LRT, showing improved local control and minimal side effects. ^{1 2 3 4 5}

Is Lattice Radiotherapy safe for humans?

Lattice Radiotherapy (LRT) has been used to treat large tumors with minimal side effects and no treatment-related deaths reported. Studies show it can safely deliver high doses of radiation to tumors while protecting nearby healthy tissue, with no significant acute or chronic toxicity observed in patients. ^{1 2 6 7 8}

What makes Lattice Radiotherapy (LRT) unique compared to other cancer treatments?

Lattice Radiotherapy (LRT) is unique because it uses a 3D approach to deliver high doses of radiation to specific parts of a large tumor while sparing surrounding areas, which helps control the tumor without increasing side effects. This method is particularly beneficial for treating large or difficult-to-reach tumors. ^{1 2 3 6 9}

Eligibility Criteria

This clinical trial is open to individuals with large, bulky tumors that are difficult to treat with standard care. Specific eligibility criteria have not been provided, so interested participants should inquire further for details.

Inclusion Criteria

My cancer can be kept still during radiation treatment.

Patients must have measurable disease

Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration

Exclusion Criteria

I haven't had certain cancer treatments 5 days before or after a specific therapy.

I have blood cancer, lymphoma, leukemia, or cancer that has spread to my brain.

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 fractions of lattice radiation therapy delivered every other day

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including toxicity evaluations and immune response analysis

8 weeks

4 visits (in-person)

Long-term Follow-up

Overall survival and quality of life are assessed

12 months

Treatment Details

Interventions

• Lattice therapy (LRT)

Trial Overview The study is testing lattice radiation therapy (LRT), a novel approach aimed at providing more effective treatment for large tumors compared to the current standard radiotherapy methods.

Participant Groups

Group I: Lattice radiation therapy (LRT) Experimental Treatment 1 Intervention

Lattice radiation therapy (LRT) : 5 fractions

Lattice therapy (LRT) is already approved in United States, China for the following indications:

Approved in United States as Lattice Radiation Therapy for:

• Bulky tumors
• Locally advanced unresectable tumors
• Palliative treatment

Approved in China as Lattice Radiation Therapy for:

• Bulky tumors
• Locally advanced unresectable tumors
• Palliative treatment

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Findings from Research

Lattice radiation therapy (LRT) appears to be safe for treating large tumors, with only two severe toxicity cases reported that had questionable links to the treatment, based on a review of 12 clinical reports involving 81 patients.

While definitive conclusions on LRT's efficacy cannot be drawn due to the low level of evidence and study variability, there is a promising trend showing that when complete tumor response is not achieved, a median reduction of approximately 50% in tumor size is observed within 3-6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lattice Radiation Therapy in clinical practice: A systematic review. Iori, F., Cappelli, A., D'Angelo, E., et al.[2023]

The Lattice Radiotherapy (LRT) technique, which enhances traditional GRID technology with 3D treatment delivery, showed promising results in a 72-year-old male patient with stage IIIA Non-Small Cell Lung Cancer, leading to no evidence of disease after 6 years.

Over 7 years, LRT has been applied to more than 30 patients, including 12 with NSCLC, demonstrating improved local control of cancer with minimal toxicity, highlighting its potential as an effective treatment for locally advanced lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved outcome of treating locally advanced lung cancer with the use of Lattice Radiotherapy (LRT): A case report. Amendola, BE., Perez, NC., Wu, X., et al.[2020]

Lattice Radiation Therapy (LRT), a modern extension of traditional GRID therapy, has been used to treat over 150 patients with bulky tumors since its introduction in 2010, showing promise in clinical practice.

Current applications of Spatially Fractionated Radiation Therapy (SFRT) like LRT are based on heuristic principles, highlighting the need for further biological research and clinical trials to optimize its efficacy and safety in treating cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). Wu, X., Perez, NC., Zheng, Y., et al.[2021]

Lattice radiation therapy (LTR) has shown excellent results in treating a large metastasis from ovarian carcinosarcoma, demonstrating its potential as an effective treatment option.

The case study involved a 61-year-old female patient who experienced positive clinical and imaging outcomes for over four years following LTR, indicating long-term efficacy of this advanced radiation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Lattice Radiation Therapy (LRT) in the Treatment of Bulky Tumors: A Case Report of a Large Metastatic Mixed Mullerian Ovarian Tumor. Blanco Suarez, JM., Amendola, BE., Perez, N., et al.[2020]

Lattice stereotactic body radiation therapy (SBRT) effectively delivers a high dose of radiation (66.7 Gy) to tumor areas while sparing surrounding healthy tissues, achieving all planning objectives for 20 patients in a Phase I trial.

The study demonstrated improved conformity of the radiation dose over time, with most treatments completed efficiently within 30 minutes, indicating that Lattice SBRT is both effective and practical for larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. Kavanaugh, JA., Spraker, MB., Duriseti, S., et al.[2022]

Lattice stereotactic body radiation therapy (SBRT) has been shown to safely deliver high doses of radiation to large tumors (≥10 cm) while minimizing side effects, making it a promising option for patients with metastatic cancer.

In a feasibility study involving 11 patients and 12 tumor targets, all treatment plans adhered to established SBRT dose constraints, indicating that Lattice SBRT can be effectively implemented using standard clinical technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Duriseti, S., Kavanaugh, J., Goddu, S., et al.[2022]

Lattice radiotherapy (LRT) demonstrated a mean tumor volume reduction of 42% in 10 patients with bulky non-small cell lung cancer (NSCLC) after treatment, indicating its efficacy in targeting large tumors.

The treatment was found to be safe, with no mortality or significant acute or chronic toxicity reported, suggesting that LRT could be a viable option for patients with unresectable tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Lattice Radiotherapy in Voluminous Non-small Cell Lung Cancer. Amendola, BE., Perez, NC., Wu, X., et al.[2020]

In a phase I trial involving 20 patients with large tumors (>5 cm), Lattice SBRT demonstrated a strong safety profile, with no likely treatment-associated grade 3 or higher acute toxicity reported within 90 days, except for one case of grade 4 toxicity.

The study successfully met its primary endpoint of short-term safety, paving the way for an ongoing phase II trial to further evaluate the long-term safety and efficacy of Lattice SBRT for treating bulky tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Duriseti, S., Kavanaugh, JA., Szymanski, J., et al.[2023]

A fully automated method for lattice radiation therapy (LRT) was developed, allowing for efficient generation and optimization of treatment plans for sarcoma patients, significantly reducing planning time to about 22 minutes on average.

The study found that specific lattice configurations, particularly those with center-to-center distances of 2.5 cm to 4 cm, provided optimal dose distribution and tumor coverage, indicating that this automated approach can enhance the efficacy of radiation therapy for large tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an automated treatment planning approach for lattice radiation therapy. Gaudreault, M., Chang, D., Kron, T., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Lattice Radiation Therapy in clinical practice: A systematic review. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Improved outcome of treating locally advanced lung cancer with the use of Lattice Radiotherapy (LRT): A case report. [2020]

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

The Technical and Clinical Implementation of LATTICE Radiation Therapy (LRT). [2021]

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

The Use of Lattice Radiation Therapy (LRT) in the Treatment of Bulky Tumors: A Case Report of a Large Metastatic Mixed Mullerian Ovarian Tumor. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. [2022]

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

Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. [2022]

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

Safety and Efficacy of Lattice Radiotherapy in Voluminous Non-small Cell Lung Cancer. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. [2023]

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

Development of an automated treatment planning approach for lattice radiation therapy. [2023]