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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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

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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.

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

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

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Systemic Therapy

2012

Completed Phase 2

~560

0 / 7Eligibility criteria met

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

13,672 Previous Clinical Trials

40,925,969 Total Patients Enrolled

Raquibul HannanPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

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

How many participants are being administered treatment as part of this experiment?

"This clinical trial mandates that 472 individuals with the appropriate inclusion criteria sign up for participation. Decatur Memorial Hospital in Chicago, Illinois and Northwestern University in Springfield, Missouri are two of many participating sites."

Answered by AI

What risks do participants in Arm II (SAbR, usual care) face?

"Through our analysis, Arm II (SAbR, usual care) earned a 3 on the safety scale as it is in phase 3 testing and has multiple datasets corroborating its efficacy."

Answered by AI

To what extent are there medical facilities carrying out this research trial in the state?

"This clinical trial is available at Decatur Memorial Hospital in Chicago, Iowa, Northwestern University in Springfield, Missouri and Southern Illinois University School of Medicine in Ames. An additional ten sites are also taking part."

Answered by AI

Is enrollment currently available for this research project?

"Affirmative. Information present on clinicaltrials.gov indicates that this study is currently seeking participants, which was first advertised on September 7th 2023 and recently modified on October 13th 2023. 472 individuals need to be recruited from 10 distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study

2023. "Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05863351.

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