What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include Stereotactic Body Radiation Therapy (SBRT), chemotherapy, and targeted therapies. SBRT, known for its precision, can still cause side effects such as pneumonitis, fatigue, and skin reactions. Chemotherapy often leads to nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts. Targeted therapies, which focus on specific genetic mutations, may cause side effects like rash, diarrhea, and liver toxicity. Personalized dose recommendations using AI for SBRT aim to minimize these side effects while effectively treating the cancer.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), including targeted therapies and immunotherapies. Notable approvals include gefitinib for EGFR mutation-positive NSCLC, which was compared to carboplatin/paclitaxel in the IPASS study. Additionally, immune checkpoint inhibitors such as nivolumab (anti-PD-1) have shown promise in treating NSCLC. These treatments aim to improve outcomes by targeting specific molecular pathways or enhancing the immune response against cancer cells. The use of AI in SBRT planning represents an innovative approach to personalize radiation doses, potentially improving the precision and effectiveness of treatment.

What other types of research exist?

Promising novel alternatives to AI-directed dose recommendation for SBRT in NSCLC patients include: 1) Proton Beam Therapy, which may offer superior survival and reduced toxicity compared to standard radiation; 2) Hypofractionated SBRT, which uses fewer, higher doses of radiation and has shown efficacy in early-stage NSCLC; 3) Integration of systemic therapies with local treatments, such as combining chemotherapy or targeted therapies with radiation to enhance treatment efficacy.

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Radiation Therapy

AI-Directed Radiation Therapy for Lung Cancer

N/A

Recruiting

Led By Mohamed E Abazeed, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be age >= 18 years

Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment

Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

SBRT may cause side effects like skin irritation at the treatment site, fatigue, shortness of breath due to inflammation in the lungs (pneumonitis), chest pain, coughing up blood (hemoptysis), difficulty swallowing (esophagitis), and potential damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I can understand and am willing to sign the consent form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently on any experimental cancer treatments or strong chemotherapy.

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I am not pregnant or nursing.

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I have had radiotherapy in the same area more than once.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

LFS

Local failure free survival (LFS)

Secondary study objectives

Dose recommended

Incidence of adverse events

Progression-free survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AI-directed analysis, SBRT)Experimental Treatment7 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy. SBRT, a form of radiation therapy, uses high precision to deliver high doses of radiation to tumors, minimizing damage to surrounding tissues. This is particularly important for NSCLC patients as it can effectively control localized tumors with fewer side effects. Chemotherapy works by killing rapidly dividing cells, while targeted therapies inhibit specific molecules involved in tumor growth, such as EGFR or ALK mutations. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These treatments are crucial for NSCLC patients as they offer various strategies to manage and potentially eradicate the disease, improving survival rates and quality of life.

Survival Outcome after Stereotactic Body Radiation Therapy and Surgery for Early Stage Non-Small Cell Lung Cancer: A Meta-Analysis.Anti-angiogenic drugs for second-line treatment of NSCLC patients: just new pawns on the chessboard?