← Back to Search

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

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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I have been diagnosed with kidney cancer through a biopsy.
Select...
My kidney cancer's main tumor has been or will be treated before joining the study.
Select...
My cancer sites can be treated with SAbR, as confirmed by a radiation oncologist.
Select...
My kidney cancer is classified as low to medium risk.
Select...
I have 2 to 5 tumors that have spread, confirmed by recent scans.
Select...
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:
Select...
I have or had inflammatory bowel disease.
Select...
I haven't had any serious wounds, ulcers, or fractures needing long care in the last 30 days.
Select...
I do not have cancer that has spread to my brain.
Select...
I have not had an irregular heartbeat in the last 6 months.
Select...
I am on high-dose steroids or immunosuppressants for an autoimmune disease.
Select...
My cancer has not spread to my lungs' center, digestive system, skin, or scalp.
Select...
I have not had systemic therapy for metastatic kidney cancer, except as part of early treatment.
Select...
I have not had major surgery in the last 30 days.
Select...
My liver function is significantly impaired.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Secondary outcome measures
Progression-free survival (PFS)
Other outcome measures
PFS-start of systemic therapy (SST)

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
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Systemic Therapy
2012
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,450 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,929 Total Patients Enrolled
Raquibul HannanPrincipal InvestigatorECOG-ACRIN Cancer Research Group
~315 spots leftby Dec 2030