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Radiation Therapy

Palliative Radiotherapy for Cancer

Phase 2
Recruiting
Led By Amy Xu, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
Must not have
Serious medical co-morbidities precluding radiotherapy
Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a lower dose of radiation to see if it is still effective against cancer that has spread and has an ATM mutation.

Who is the study for?
This trial is for adults over 18 with a life expectancy of at least 6 months who have cancer that has spread and shows a specific genetic change (ATM mutation). They should be able to undergo reduced-dose radiation therapy, not previously treated in the same area, and must agree to use effective contraception.
What is being tested?
The study is examining if lower doses of radiation can still effectively treat metastatic tumors with an ATM mutation. It aims to determine the minimum effective dose of palliative radiotherapy for these patients.
What are the potential side effects?
While not specified here, common side effects from reduced-dose radiation may include skin irritation, fatigue, mild swelling or pain around the treatment area. The severity often depends 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 take care of myself and perform daily activities.
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My cancer has spread, and I am referred for symptom relief radiation.
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I am 18 years old or older.
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I have a genetic mutation in the ATM gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have health conditions that prevent me from receiving radiation therapy.
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I've had radiation before where we plan to treat, and can't have more without risking harm.
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My cancer has a p53 gene mutation.
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My cancer has not spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment failure rate of irradiated lesion

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: radiationExperimental Treatment1 Intervention
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative radiotherapy
2015
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,709 Total Patients Enrolled
Amy Xu, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
185 Total Patients Enrolled

Media Library

Palliative radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05010031 — Phase 2
Cancer Research Study Groups: radiation
Cancer Clinical Trial 2023: Palliative radiotherapy Highlights & Side Effects. Trial Name: NCT05010031 — Phase 2
Palliative radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010031 — Phase 2
~10 spots leftby Aug 2026
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