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Radiation Therapy

SBRT Guided by PET Scans for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Arya Amini

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed NSCLC with 1-5 sites of disease progression while on or following systemic therapy with a checkpoint inhibitor with or without chemotherapy for at least 3 months with radiographic evidence of progression based on Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)

Age: >= 18 years

Must not have

Those not eligible for SBRT after review by a radiation oncologist

Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3, 6, and 12 months following radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the use of PET scans to guide SBRT to treat NSCLC, melanoma, and RCC with fewer doses and less damage to normal tissue.

Who is the study for?

This trial is for adults with certain cancers (NSCLC, melanoma, RCC) that have spread to up to 5 places. Patients must have had prior treatment and controlled primary tumor for over 3 months or be treated with intent to control. They need a life expectancy of at least 3 months and be able to undergo PET/CT scans.

What is being tested?

The trial tests PET-guided SBRT's safety and effectiveness in treating oligoprogressive cancer compared to standard SBRT. It aims to deliver precise radiation doses while minimizing damage to healthy tissue by using advanced imaging techniques.

What are the potential side effects?

Potential side effects include skin reactions, fatigue, inflammation of organs near the treated area due to radiation exposure, and possible changes in blood counts. The exact side effects will depend on the individual's response and the areas being treated.

Eligibility Criteria

Inclusion Criteria

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

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My NSCLC has worsened on treatment, confirmed by tests.

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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 50% of my waking hours.

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I have a cancer lesion that will receive a lower radiation dose to protect nearby organs.

Exclusion Criteria

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

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A radiation oncologist determined I can't have SBRT.

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I am not pregnant or breastfeeding and have a negative pregnancy test.

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I cannot have a PET/CT scan or my disease does not show up on PET scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 6, and 12 months following radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 6, and 12 months following radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6, and 12 months following radiation therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)

Secondary study objectives

Dose delivered

Incidence of adverse events

Local control rates

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: ARM II: (PET guided SBRT)Experimental Treatment5 Interventions

ARM II: Patients undergo 3 SBRT treatments every other day week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Patients also undergo CT or PET/CT and blood collection throughout study.

Group II: ARM I: (standard care SBRT)Experimental Treatment5 Interventions

Patients undergo 5 SBRT treatments every other day on study. Patients also undergo CT or PET/CT and blood collection throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Biospecimen Collection

2004