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mTOR inhibitor
Everolimus for Kidney Cancer (S0931 Trial)
Phase 3
Waitlist Available
Led By Christopher W. Ryan, MD
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
Considered pathologically either intermediate high-risk or very high-risk disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years from registration
Awards & highlights
S0931 Trial Summary
This trial is studying everolimus to see how effective it is in treating kidney cancer patients who have undergone surgery.
Who is the study for?
This trial is for adults who've had surgery for kidney cancer, with no remaining or spreading cancer detectable by CT/MRI scans. They should be in good physical condition (Zubrod status 0-1), have proper organ function, and not be pregnant. Participants must use effective contraception and be able to take oral medications. Those with heart disease, severe liver impairment, HIV, uncontrolled diabetes or cholesterol levels, allergies to everolimus components, or other recent cancers are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of Everolimus in preventing kidney cancer from returning after surgery. Patients will either receive Everolimus or a placebo (a pill without active medication) to compare outcomes between the two groups.See study design
What are the potential side effects?
Everolimus may cause side effects like mouth sores, infections due to a weakened immune system, lung problems such as coughing and shortness of breath, elevated blood sugar and cholesterol levels, skin issues like rash or acneiform dermatitis.
S0931 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer has spread to small blood vessels but not to distant parts.
Select...
My condition is classified as intermediate high-risk or very high-risk.
Select...
I have had surgery to remove my kidney and any affected lymph nodes.
Select...
My kidney cancer diagnosis was confirmed through lab tests.
Select...
I can carry out all my usual activities without help.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My surgery removed all visible cancer.
S0931 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years from registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
5-year Recurrence-free Survival (RFS)
Secondary outcome measures
5-year Overall Survival (OS)
Frequency and Severity of Toxicities
Side effects data
From 2019 Phase 3 trial • 235 Patients • NCT0317623863%
Stomatitis
27%
Decreased appetite
26%
Hyperglycaemia
25%
Aspartate aminotransferase increased
24%
Rash
23%
Alanine aminotransferase increased
22%
Cough
19%
Anaemia
16%
Weight decreased
16%
Fatigue
16%
Blood cholesterol increased
15%
Gamma-glutamyltransferase increased
15%
Diarrhoea
13%
Pneumonitis
12%
Upper respiratory tract infection
12%
Headache
12%
Nausea
12%
Hypertriglyceridaemia
11%
Back pain
11%
Pruritus
9%
Myalgia
9%
Insomnia
9%
Blood lactate dehydrogenase increased
8%
Arthralgia
8%
Dyspnoea
8%
Productive cough
8%
Dyspepsia
8%
Oedema peripheral
7%
Dysgeusia
7%
Pain in extremity
6%
Constipation
6%
Pyrexia
6%
Hypertension
5%
Hypercholesterolaemia
5%
Aphthous ulcer
5%
Dyslipidaemia
5%
Neutrophil count decreased
5%
Asthenia
5%
Pneumonia
5%
Urinary tract infection
5%
Lymphoedema
5%
Epistaxis
5%
Thrombocytopenia
5%
Blood alkaline phosphatase increased
5%
Dry skin
4%
Abdominal pain
4%
Hypokalaemia
4%
Hypophosphataemia
4%
Mouth ulceration
4%
Toothache
4%
Peripheral swelling
4%
Rhinorrhoea
4%
Acne
4%
Urticaria
4%
Blood creatinine increased
3%
Cellulitis
3%
Abdominal discomfort
3%
White blood cell count decreased
3%
Face oedema
3%
Vomiting
3%
Nail disorder
3%
Abdominal pain upper
3%
Diabetes mellitus
3%
Depression
3%
Non-cardiac chest pain
3%
Influenza
3%
Nasopharyngitis
3%
Pharyngitis
3%
Haemoglobin decreased
3%
Oropharyngeal pain
3%
Hyperkalaemia
3%
Hyperlipidaemia
3%
Paraesthesia
3%
Alopecia
3%
Dermatitis acneiform
2%
Influenza like illness
2%
Mucosal inflammation
2%
Flank pain
2%
Neck pain
2%
Musculoskeletal pain
2%
Platelet count decreased
2%
Eczema
2%
Hypoaesthesia
2%
Onychomadesis
2%
Dizziness
2%
Rash maculo-papular
2%
Haemorrhoids
2%
Pain
2%
Vitamin D deficiency
2%
Pleural effusion
2%
Blood triglycerides increased
1%
Gastric ulcer
1%
Abdominal distension
1%
Ascites
1%
Urosepsis
1%
Cardiopulmonary failure
1%
Vision blurred
1%
Gait inability
1%
Haematochezia
1%
Bone pain
1%
Cartilage injury
1%
Femur fracture
1%
Ligament sprain
1%
Eastern cooperative oncology group performance status worsened
1%
Interstitial lung disease
1%
Liver function test increased
1%
Urethritis
1%
Ingrowing nail
1%
Eye pain
1%
Joint stiffness
1%
Tachycardia
1%
Atypical pneumonia
1%
Herpes virus infection
1%
Gastroenteritis
1%
Spinal pain
1%
Muscular weakness
1%
Onycholysis
1%
Asthma
1%
Contrast media allergy
1%
Dehydration
1%
Viral infection
1%
Soft tissue infection
1%
Cardiac failure
1%
Large intestinal haemorrhage
1%
Hyponatraemia
1%
Dental caries
1%
Hypomagnesaemia
1%
Pain in jaw
1%
Cardiac arrest
1%
Left ventricular failure
1%
Ventricular tachycardia
1%
Abdominal hernia
1%
Diabetes mellitus inadequate control
1%
Joint effusion
1%
Metastases to lung
1%
Folliculitis
1%
Furuncle
1%
Gingivitis
1%
Lower respiratory tract infection
1%
Oral herpes
1%
Sinusitis
1%
Hypocalcaemia
1%
Breast pain
1%
Dyspnoea exertional
1%
Haemoptysis
1%
Wheezing
1%
Palmar-plantar erythrodysaesthesia syndrome
1%
Hot flush
1%
Atrial fibrillation
1%
Dysphagia
1%
Gastric haemorrhage
1%
Tumour necrosis
1%
Gastrooesophageal reflux disease
1%
Oral pain
1%
Musculoskeletal chest pain
1%
Rash papular
1%
Rash pruritic
1%
Respiratory failure
1%
Skin ulcer
1%
Pulmonary embolism
1%
Pulmonary oedema
1%
Overdose
1%
Leukopenia
1%
Neutropenia
1%
Tumour pain
1%
Central nervous system haemorrhage
1%
Hydrocephalus
1%
Intracranial aneurysm
1%
Lethargy
1%
Acute kidney injury
1%
Renal failure
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Asian
Non-Asian
S0931 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IExperimental Treatment1 Intervention
Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm IIPlacebo Group1 Intervention
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
everolimus
2005
Completed Phase 3
~1550
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
263,625 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,608 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unstable chest pain.I have severe heart disease.I have not had a heart attack in the last 6 months.My cholesterol is over 300 mg/dL and my triglycerides are more than 2.5 times the upper limit.My blood sugar levels are controlled and monitored.My kidney cancer has spread to small blood vessels but not to distant parts.I have tested positive for HIV.I cannot have IV iodine-based or gadolinium contrast due to health reasons.I have no cancer history, except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.I have not received any treatment for kidney cancer before.I am not currently taking steroids or other drugs that weaken my immune system.My condition is classified as intermediate high-risk or very high-risk.I do not have an uncontrolled serious heart rhythm problem.I have had surgery to remove my kidney and any affected lymph nodes.My kidney cancer diagnosis was confirmed through lab tests.Your ANC (absolute neutrophil count) is at least 1,500 per cubic millimeter.I do not have severe liver disease or cirrhosis.I haven't taken strong CYP3A4 affecting drugs in the last 14 days.My stomach and intestines work well and don't have diseases that affect medication absorption.I can safely receive IV iodine-based contrast or gadolinium.My cholesterol levels are controlled and will be monitored.Your platelet count is at least 100,000 per cubic millimeter.Your bilirubin level in the blood is not more than 1.5 times the upper limit of normal.Your SGOT and SGPT liver enzyme levels are not more than 2.5 times the upper limit of normal.My kidney cancer has not spread into the wall of the renal vein.I registered for the trial within 84 days after my first tumor surgery.I can carry out all my usual activities without help.My kidney function, measured by creatinine levels, is within the normal range.I can take pills by mouth.I am allergic to everolimus, sirolimus, temsirolimus, or their ingredients.I can have MRI scans if I can't have CT scans with contrast.My surgery removed all visible cancer.My cancer can be clear cell or non-clear cell type.I have a lung condition that is not currently under control.I haven't had a live vaccine in the last 7 days.My blood sugar levels are not controlled and are higher than normal.I am not currently taking any cancer treatments or experimental drugs.My recent scans show no signs of kidney cancer after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II
- Group 2: Arm I
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the most frequent uses of everolimus?
"Patients that have undergone organ transplantation, have kidney disease, or have been diagnosed with Waldenstrom macroglobulinemia or lung cancer can be treated with everolimus."
Answered by AI
Is this the first time everolimus has been trialed?
"Everolimus was first studied in 2008 at the Sheba Medical Center. So far, 3085 completed trials have been conducted on the medication. Out of the 99 active trials, a sizable number are taking place in Hendersonville, North carolina."
Answered by AI
Could you give me an estimate of how many people are participating in this trial?
"As of right now, this study is not enrolling patients. The trial was first posted on April 1st, 2011 and was most recently updated on July 20th, 2022. However, there are 435 other clinical trials for carcinoma, renal cell and 99 trials for everolimus that are currently looking for patients."
Answered by AI
Are there any patients who could still join this clinical trial?
"According to the most recent information available on clinicaltrials.gov, this particular trial is not enrolling patients at the moment. The trial was first announced on 4/1/2011 and was last updated on 7/20/2022. There are, however, 534 other clinical trials that are actively recruiting patients."
Answered by AI
Has everolimus been cleared by the FDA?
"There is some evidence from earlier clinical trials to support the efficacy of everolimus as well as data from multiple safety trials. Consequently, our team rates everolimus as a 3 on our safety scale."
Answered by AI
Is this study still enrolling patients who are less than 85 years old?
"According to the inclusion criteria for this clinical trial, patients must be between 18-120 years old to be applicable. There are 45 trials for patients under 18 and 512 for patients over 65."
Answered by AI
Could I potentially enroll in this experiment?
"This study is testing a new cancer treatment and is looking for 1545 participants that have been diagnosed with carcinoma, renal cell. In order to be eligible, patients must be between the ages of 18 and 120."
Answered by AI
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