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Radiation

Focused Radiation vs Systemic Therapy for Kidney Cancer

Phase 3

Recruiting

Led By Raquibul Hannan

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must be >= 18 years of age

Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization

Must not have

History of or active inflammatory bowel disease

Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death from any cause, assessed up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares a new radiotherapy approach to usual care to see if it can improve outcomes in metastatic kidney cancer.

Who is the study for?

Adults with kidney cancer that has spread to 2-5 other body parts, who've had local treatment for the primary tumor and are in good physical condition (ECOG 0-2). They must not be pregnant, have brain metastases, severe allergies to certain antibodies, recent heart issues or surgeries. People with HIV or hepatitis can join if treated and controlled.

What is being tested?

The trial is testing whether using focused radiation (SAbR) before standard systemic therapy (like immunotherapy or molecular inhibitors) is more effective than systemic therapy alone for treating limited metastatic kidney cancer.

What are the potential side effects?

Potential side effects include typical reactions from radiotherapy like skin irritation and fatigue as well as those from systemic therapies such as immune-related reactions, nausea, liver function changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with kidney cancer through a biopsy.

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My kidney cancer's main tumor has been or will be treated before joining the study.

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My cancer sites can be treated with SAbR, as confirmed by a radiation oncologist.

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My kidney cancer is classified as low to medium risk.

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I have 2 to 5 tumors that have spread, confirmed by recent scans.

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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 have or had inflammatory bowel disease.

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I haven't had any serious wounds, ulcers, or fractures needing long care in the last 30 days.

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I do not have cancer that has spread to my brain.

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I have not had an irregular heartbeat in the last 6 months.

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I am on high-dose steroids or immunosuppressants for an autoimmune disease.

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My cancer has not spread to my lungs' center, digestive system, skin, or scalp.

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I have not had systemic therapy for metastatic kidney cancer, except as part of early treatment.

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I have not had major surgery in the last 30 days.

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My liver function is significantly impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death from any cause, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death from any cause, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death from any cause, assessed up to 10 years 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 (AEs)

Overall survival (OS)

Secondary study objectives

Progression-free survival (PFS)

Other study objectives

PFS-start of systemic therapy (SST)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (SAbR, usual care)Experimental Treatment5 Interventions

Patients undergo repeated SAbR until progression and then receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial.

Group II: Arm I (usual care)Active Control4 Interventions

Patients receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Computed Tomography

2017