AI-Directed Radiation Therapy for Lung Cancer

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Genotoxic chemotherapy

Disqualifiers: Prior radiotherapy, Active infection, Unstable angina, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires patients to pause targeted therapy medications 3 days before and restart them at least 3 days after the radiation therapy. Other medications, including non-investigational immunotherapy and COVID-19 vaccinations, are allowed.

What data supports the effectiveness of the treatment AI-Directed Dose Recommendation, Stereotactic Body Radiation Therapy, SBRT, Stereotactic Ablative Radiotherapy, SABR, Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for lung cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR), especially using the CyberKnife system, is effective for treating early-stage non-small cell lung cancer, offering high rates of local tumor control with acceptable side effects. It is particularly beneficial for patients who cannot undergo surgery, providing a precise and non-invasive treatment option. ^{1 2 3 4 5}

Is AI-Directed Radiation Therapy for Lung Cancer safe for humans?

Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system has been shown to have acceptable safety levels, with manageable side effects, when used for treating lung cancer. Studies indicate that it provides good tumor control with a short treatment duration, making it a safe option for patients who cannot undergo surgery. ^{1 2 3 4 6}

How is the treatment AI-Directed Radiation Therapy for Lung Cancer different from other treatments?

AI-Directed Radiation Therapy using the CyberKnife system is unique because it delivers high doses of radiation with precision to lung tumors that move with breathing, using a robotically-controlled system that adjusts in real-time. This allows for effective treatment in fewer sessions compared to conventional radiotherapy, making it suitable for patients who cannot undergo surgery. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if using AI to decide radiation doses can improve treatment for lung cancer patients. The AI aims to make radiation therapy more precise and effective, reducing the chance of cancer returning. The study will see if this approach helps patients live longer without their cancer getting worse and if it is safe and practical to use in real-life settings.

Research Team

Mohamed E. Abazeed

Principal Investigator

Northwestern University

Eligibility Criteria

Adults (18+) with primary lung cancer or a few metastatic tumors in the lungs, able to perform daily activities (ECOG 0-2), and not pregnant can join. They must understand and sign consent. Excluded are those with prior overlapping radiotherapy, unresolved thoracic toxicities from past treatments, concurrent investigational drugs, other interfering malignancies, or uncontrolled illnesses.

Inclusion Criteria

Patients must have visible signs of disease on a medical scan that can be measured according to specific guidelines.

My lung scans show signs of cancer, either as a primary condition or with few spread sites.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

If you have a specific type of lung cancer that appears as only hazy spots on a scan, you will not be included in the study.

I do not have another cancer or serious illness that could affect the study.

I still have side effects from cancer treatment in my chest area, except for hair loss or low blood counts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation Planning

Radiation planning with AI-directed analysis for dose recommendations using Deep Profiler + iGray software

1 week

1 visit (in-person)

Treatment

Participants undergo stereotactic body radiation therapy (SBRT) with AI-directed dose recommendations

1-2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging and respiratory function assessment

5 years

Regular visits (in-person)

Treatment Details

Interventions

• AI-Directed Dose Recommendation
• Stereotactic Body Radiation Therapy

Trial Overview The RAD-AI study is testing if AI can improve dose recommendations during SBRT for lung cancer treatment. It aims to see if personalized AI predictions lead to better outcomes by reducing local recurrence of the disease while minimizing damage to healthy tissue.

Participant Groups

Group I: Treatment (AI-directed analysis, SBRT) Experimental Treatment 7 Interventions

Patients undergo radiation planning with AI-directed analysis for dose recommendations with Deep Profiler + iGray software on study. Patients then undergo SBRT on study. Patients also undergo PET, CT, MRI, and/or x-ray imaging during screening and follow-up.

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancer, especially for patients who cannot undergo surgery, showing high local tumor control rates with manageable side effects.

The CyberKnife system is particularly advantageous for SABR in lung tumors due to its ability to accurately target moving tumors during breathing, enhancing treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic ablative radiotherapy for lung tumors. Gibbs, IC., Loo, BW.[2022]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2022]

In a study of 73 patients with metastatic lung tumors treated using the CyberKnife system, stereotactic ablative body radiotherapy (SABR) demonstrated high effectiveness, achieving a 2-year local control rate of 89.1% and an overall survival rate of 71.3%.

The treatment was associated with acceptable toxicity levels, with only two cases of grade 2 or higher radiation pneumonitis, indicating that SABR with a central high dose is a safe option for managing metastatic lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. Hayashi, K., Suzuki, O., Shiomi, H., et al.[2023]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

References

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

CyberKnife stereotactic ablative radiotherapy for lung tumors. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. [2020]

3. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy with a central high dose using CyberKnife for metastatic lung tumors. [2023]

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

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

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. [2022]