RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial (NCT07625930) | Clinical Trial Compass
Not Yet RecruitingPhase 2
RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial
Canada184 participantsStarted 2027-01
Plain-language summary
Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed.
This study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival.
In this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer.
If successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed, informed consent.
. Age, 18 years or older.
. Histological diagnosis of adenocarcinoma or poorly differentiated carcinoma of the esophagus or EGJ.
. The tumour must be deemed potentially resectable by the surgical team. This assessment is based on complete staging imaging studies (detailed below) - clinical staging of the tumor and ruling out metastatic disease.
. Locally advanced disease as defined per AJCC/UICC 8th edition37: stage IIA, IIB, III, IVA (T1-4a N2-3).
. Eligibility for standard-of-care perioperative systemic therapy with FLOT+/-D.
. Life expectancy greater than 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MPR
Timeframe: From enrolment to surgical pathology assessment, 16 weeks
Trial details
NCT IDNCT07625930
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
. History of allergic reactions to simvastatin or atorvastatin or similar chemical or biological compounds.
. Ongoing cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors), in which case the patient is offered enrollment in the observational arm.
. Hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).
. Predisposing factors for rhabdomyolysis: hypothyroidism, reduced renal function, muscle disease, or excessive alcohol consumption AND creatine kinase up to less than five times the upper limit (measured in the presence of predisposing factors).
. Concurrent medication with potent CYP3A4-inhibitors, e.g. ketokonazole, erythromycin, gemfibrozil, cyclosporine, or danazol.
. Pre-existing medical conditions precluding treatment, including any contraindication systemic chemotherapy or major surgery.
. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, discussed before registration in the trial.