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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
Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation
Pathologically confirmed diagnosis of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I can keep getting my regular immune therapy while I have radiation treatment.
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My cancer diagnosis was confirmed through lab tests.
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My cancer has worsened despite immunotherapy, or I need urgent radiation therapy.
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My cancer progressed despite immunotherapy or cell-based treatment.
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I have at least one cancer spot that can be treated with radiation.
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I have had radiation before, but not where I'm getting it now or only in low doses.
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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 have taken a pregnancy test in the last 28 days and it was negative.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Number of patients with stable disease
Objective response (partial response or complete response)
Secondary outcome measures
Overall survival
Progression free survival

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
~780
External Beam Radiation Therapy
2006
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,214 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,626 Previous Clinical Trials
40,927,485 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
290 Total Patients Enrolled

Media Library

External Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02710253 — Phase 2
Blood Cancers Research Study Groups: Treatment (SBRT or EBRT)
Blood Cancers Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT02710253 — Phase 2
External Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02710253 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction External Beam Radiation Therapy as a treatment?

"Our team evaluated the safety of External Beam Radiation Therapy as a 2 due to limited evidence in regards to its efficacy, while some data exists that supports it's security."

Answered by AI

What is the present enrollment of this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical research trial, launched on May 25th 2016, is actively recruiting participants. 150 people are sought to be enrolled at a single site."

Answered by AI

Are there still opportunities for participants to join this investigation?

"Per clinicaltrials.gov, the research project is actively searching for participants with its last update on June 14th 2022 and initial post date of May 25th 2016."

Answered by AI
~3 spots leftby May 2024