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Radiation Therapy
SBRT for Kidney Cancer
New Haven, CT
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.
See full description
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
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 • NCT0204544687%
Fatigue
53%
Nausea
33%
Cough
27%
Depression
27%
Dyspnea
27%
Fall
27%
Anemia
27%
Pain
27%
Lymphocyte count decreased
27%
Platelet count decreased
20%
Chills
20%
Neutropenia
20%
Diarrhea
20%
Dizziness
20%
Chest pain
20%
Edema limbs
13%
Edema
13%
Skin infection
13%
Constipation
13%
Delirium
13%
Insomnia
13%
Dysesthesia
13%
Tinnitus
13%
Dysgeusia
13%
Myalgia
13%
Vomiting
13%
Weight loss
13%
Rash
13%
Back pain
13%
Weakness (limb)
7%
Headache
7%
Proteinuria
7%
Gait disturbance
7%
Oral lesions
7%
Hypokalemia
7%
Seizures
7%
Weakness (facial)
7%
Neutrophil count decreased
7%
Hearing impaired
7%
Bruising
7%
Anxiety
7%
Death NOS
7%
Cognitive disturbance
7%
Creatinine increased
7%
Acute kidney injury
7%
Anorexia
7%
Hypomagnesemia
7%
Lymphocytopenia
7%
Nasal congestion
7%
Hearing loss
7%
Hypertension
7%
Low white blood count
7%
Pleural effusion
7%
Tremor
7%
Urinary urgency
7%
Amnesia
7%
Hypernatremia
7%
Photophobia
7%
Urinary frequency
7%
Dysphagia
7%
Muscle weakness
7%
Sneezing
7%
Erythema multitforme
7%
Lung infection
7%
Allergy (seasonal)
7%
Parathesia (tingling)
7%
Febrile Neutropenia
7%
Fever
7%
Hypoxic respiratory failure
7%
Headaches
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
Closest Location:Yale University· New Haven, CT· 1346 miles
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,952 Previous Clinical Trials
3,043,511 Total Patients Enrolled
Kimberly Johung, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during and for 6 months after the study.I've had radiation before, but my current treatment plan meets safe dose limits.I am currently being treated for an infection.I received radiation therapy less than 2 weeks ago.I have an immune system disorder or have been on strong immune-weakening medicines recently.I received radiation therapy less than 2 weeks ago.I have had lung inflammation treated with steroids, or currently have lung inflammation or scarring.My cancer has spread to my brain but not extensively.I am able to care for myself and perform daily activities.My recent tests show my organs are functioning well.I am using effective birth control or practicing true abstinence.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I don't need strong medication for an autoimmune disease now, except for minor exceptions.My kidney cancer has spread, as shown on scans.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or treated cervical cancer.My cancer has spread, but the number of areas affected doesn't limit my eligibility.You are expected to live for at least 6 more months.My last treatment was an immune therapy, taken for at least 3 months before my cancer progressed.I am currently on a TKI treatment for my kidney cancer.You have current Hepatitis B or C infection.I cannot undergo radiotherapy due to serious health conditions like lung disease or lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Body Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.