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Radiation Therapy

Radiation Therapy for Metastatic Cancer

Phase 2

Recruiting

Led By James Welsh

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed diagnosis of cancer

Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy

Must not have

Has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previous treatment

Has an active infection requiring intravenous systemic therapy or hospital admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing radiation therapy as a possible treatment for cancer that has spread to other parts of the body or gotten worse after receiving immunotherapy.

Who is the study for?

This trial is for patients with metastatic cancer that has grown despite immunotherapy. They must have a cancer diagnosis, be able to consent, and continue standard care if needed. Participants should have at least one tumor suitable for radiation and an ECOG performance status of 0-2. Women of childbearing age need a recent negative pregnancy test.

What is being tested?

The study tests the effectiveness and optimal dose of radiation therapy (Stereotactic Body Radiation Therapy or External Beam Radiation Therapy) in controlling metastatic cancers after progression on immunotherapy. It also involves laboratory biomarker analysis to understand treatment impact.

What are the potential side effects?

Radiation therapy may cause side effects such as skin irritation, fatigue, nausea, and potential damage to nearby organs or tissues depending on the area treated. The severity can vary from mild to more significant based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

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My cancer diagnosis was confirmed through lab tests.

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My cancer progressed despite immunotherapy or cell-based treatment.

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

Exclusion Criteria

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

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I still have side effects from previous treatments that are not mild.

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I am currently receiving IV treatment or am hospitalized for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Number of patients with stable disease

Objective response (partial response or complete response)

Secondary study objectives

Overall survival

Progression free survival

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 (SBRT or EBRT)Experimental Treatment3 Interventions

Patients undergo either 4, 5, or 10 fractions of SBRT, or 5-15 fractions of EBRT to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least SD after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

External Beam Radiation Therapy

2006

Completed Phase 3

~3300