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Radiation Therapy

SBRT for Kidney Cancer

Phase 2
Recruiting
Led By Kimberly Johung, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has a performance status of 0, 1, or 2 on the ECOG Performance Scale
Be ≥ 18 years of age on day of signing informed consent
Must not have
Has a history of (non-infectious) pneumonitis that required steroids, current pneumonitis or evidence of interstitial lung disease
Has an active infection requiring systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights
No Placebo-Only Group

Summary

This trialwill test if radiation therapy helps treat metastatic renal cancer in patients using an immune checkpoint inhibitor.

Who is the study for?
Adults with metastatic renal cell carcinoma currently on immune checkpoint inhibitors, who have developed 1-5 new lesions. They must not be pregnant or breastfeeding, agree to use effective birth control, and have a life expectancy over 6 months. Excluded are those with recent radiation therapy, live vaccines taken recently, certain autoimmune diseases or infections, brain-only oligoprogression, and serious conditions that preclude radiotherapy.
What is being tested?
The trial is testing Stereotactic Body Radiation Therapy (SBRT) for patients whose kidney cancer has progressed in a limited number of areas while they're being treated with immune checkpoint inhibitors. The goal is to see if SBRT can stop the cancer from getting worse.
What are the potential side effects?
While specific side effects aren't listed here for SBRT in this context, common ones include fatigue, skin reactions at the treatment site, soreness similar to sunburns; more rarely it may cause issues related to the area being treated like shortness of breath if lungs are involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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My kidney cancer has spread, as shown on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung inflammation treated with steroids, or currently have lung inflammation or scarring.
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I am currently being treated for an infection.
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I received radiation therapy less than 2 weeks ago.
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I received radiation therapy less than 2 weeks ago.
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I have not received a live vaccine in the last 30 days.
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I am currently on a TKI treatment for my kidney cancer.
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I cannot undergo radiotherapy due to serious health conditions like lung disease or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two 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
Progression Free Survival
Secondary study objectives
Overall survival
Rate of Response
Recurrence

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
87%
Fatigue
53%
Nausea
33%
Cough
27%
Pain
27%
Fall
27%
Dyspnea
27%
Depression
27%
Lymphocyte count decreased
27%
Platelet count decreased
27%
Anemia
20%
Chills
20%
Dizziness
20%
Chest pain
20%
Neutropenia
20%
Diarrhea
20%
Edema limbs
13%
Dysesthesia
13%
Insomnia
13%
Edema
13%
Constipation
13%
Delirium
13%
Dysgeusia
13%
Skin infection
13%
Vomiting
13%
Tinnitus
13%
Rash
13%
Myalgia
13%
Back pain
13%
Weakness (limb)
13%
Weight loss
7%
Proteinuria
7%
Bruising
7%
Hearing loss
7%
Anxiety
7%
Oral lesions
7%
Headaches
7%
Acute kidney injury
7%
Hypokalemia
7%
Lymphocytopenia
7%
Seizures
7%
Weakness (facial)
7%
Hearing impaired
7%
Neutrophil count decreased
7%
Death NOS
7%
Hypertension
7%
Headache
7%
Creatinine increased
7%
Fever
7%
Pleural effusion
7%
Gait disturbance
7%
Nasal congestion
7%
Tremor
7%
Urinary urgency
7%
Amnesia
7%
Hypernatremia
7%
Photophobia
7%
Urinary frequency
7%
Dysphagia
7%
Low white blood count
7%
Sneezing
7%
Cognitive disturbance
7%
Erythema multitforme
7%
Lung infection
7%
Allergy (seasonal)
7%
Muscle weakness
7%
Hypomagnesemia
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Anorexia
7%
Hypoxic respiratory failure
7%
Sleep apnea
7%
Encephalopathy
7%
Hypoxia
7%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Chemotherapy
Stereotactic Body Radiation Therapy

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: Stereotactic Body Radiation TherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,428 Total Patients Enrolled
Kimberly Johung, MDPrincipal InvestigatorYale University

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04974671 — Phase 2
Kidney Cancer Research Study Groups: Stereotactic Body Radiation Therapy
Kidney Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT04974671 — Phase 2
Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04974671 — Phase 2
~7 spots leftby Oct 2025
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