Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years
Awards & highlights
Study 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.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.
Select...
I am 18 years old or older.
Select...
My kidney cancer has spread, as shown on scans.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall survival
Rate of Response
Recurrence
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Creatinine increased
7%
Otitis externa
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Blurred vision
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Hypertension
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
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
~780
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,183 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have any open recruitment spots for this trial?
"Affirmative, according to clinicaltrials.gov this study is still recruiting volunteers. The recruitment effort was initiated on August 8th 2022 and recently updated on December 6th of the same year. 30 participants are needed at a single medical facility."
Answered by AI
What risks have been associated with Stereotactic Body Radiation Therapy?
"Our team at Power rated Stereotactic Body Radiation Therapy's safety a 2 since the trial is in Phase 2, which provides evidence of its security but no proof that it works."
Answered by AI
What is the enrollment size of this clinical trial?
"Affirmative, the information available on clinicaltrials.gov reflects that this study is actively recruiting participants; first posted in August 2022 and last updated December 6th of the same year. To complete the trial, 30 patients are needed at one site only."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger