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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
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
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
~3150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,423 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,718 Previous Clinical Trials
40,963,161 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can keep getting my regular immune therapy while I have radiation treatment.I've had radiation therapy in the last 3 months where the treatment areas might overlap.I have lasting side effects from treatment that are not severe or have been managed.I may have minor lab or skin issues, but my doctor thinks I can still join the study.I still have side effects from previous treatments that are not mild.I have fully recovered from any major surgery before starting treatment.I am currently receiving IV treatment or am hospitalized for an infection.My cancer diagnosis was confirmed through lab tests.My cancer has worsened despite immunotherapy, or I need urgent radiation therapy.My cancer progressed despite immunotherapy or cell-based treatment.I have at least one cancer spot that can be treated with radiation.I have had radiation before, but not where I'm getting it now or only in low doses.I can take care of myself and am up and about more than half of my waking hours.I have taken a pregnancy test in the last 28 days and it was negative.My doctor thinks my rheumatic condition makes radiation unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SBRT or EBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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