Not yet recruitingPHASE2INTERVENTIONAL

RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial

The RESTAGE study is exploring a new way to treat cancers of the gullet (oesophagus) and stomach (gastroesophageal junction), which are often hard to cure. Even with chemotherapy and surgery, patients can face a tough battle. This trial investigates whether adding simvastatin, a widely used and safe cholesterol-lowering medicine, to standard cancer treatment can make a difference. Early research suggests simvastatin might help slow cancer growth. Patients in this study will receive their usual chemotherapy before surgery. Half of them will also take simvastatin daily for up to two years. Researchers will compare how well tumours respond and if patients stay cancer-free for longer. If successful, this could be a simple, low-cost way to improve outcomes without many extra side effects.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

184

Start

01 Jan 2027

Estimated completion

01 Apr 2031

Gastroesophageal Adenocarcinoma

What is this study about?

Cancers of the food pipe (oesophagus) and the area where it meets the stomach (gastroesophageal junction) are serious conditions. Although treatments like chemotherapy and surgery are available, these cancers can still be very challenging, and doctors are always looking for better ways to help patients. This study, called RESTAGE, is investigating if we can improve current treatments by adding a widely-used and affordable medicine.

The idea behind this study is to see if a common cholesterol-lowering tablet called simvastatin, which many people take safely for years, can also help fight cancer. Previous research has hinted that simvastatin might be able to slow down the growth of cancer cells. If this is true, adding it to the standard cancer treatments like chemotherapy could potentially make the chemotherapy work even better and help prevent the cancer from returning.

In this trial, patients will receive the usual chemotherapy, sometimes with immunotherapy, before having surgery. Half of these patients will also take simvastatin tablets every day for up to two years. The main goal is to compare how well the tumours shrink and how long patients stay free of cancer. If this simple addition works, it could offer a very practical and cost-effective way to improve the chances of a good outcome for people with these types of cancer, without causing many new side effects.

Key takeaways

Exploring if a common cholesterol drug can boost cancer treatment.
Aims to improve outcomes for stomach and gullet cancers.
Simvastatin is generally safe, inexpensive, and widely used.
Patients receive standard chemotherapy plus (or minus) simvastatin.
If successful, it could be a simple new treatment option.
Participation involves daily tablets and regular check-ups.

Who may be eligible?

To join this study, you would need to be 18 years or older and have a specific type of cancer in your food pipe or stomach that doctors believe can be removed with surgery. Your cancer should also be at a stage where standard chemotherapy is usually given before an operation. It's important that you generally feel well enough to go through treatment and that you're expected to live for more than three months.

There are also some reasons why you might not be able to join. For example, if you’ve had cancer in your food pipe or stomach before, or if you're allergic to simvastatin or similar medicines. You also can’t take part if you’re already on other strong cholesterol-lowering drugs, or if you have severe liver or kidney problems. Your doctors will also check if any other health conditions or medications you’re taking might interfere with the study treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older?
Do you have a certain type of stomach or gullet cancer that may be surgically removed?
Are you well enough for standard chemotherapy and surgery?
Have you ever had an allergic reaction to simvastatin or similar medicines? (If yes, you may not be eligible.)
Are you currently taking strong cholesterol-lowering medications? (If yes, you may not be eligible.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive your standard chemotherapy treatment, which might also include immunotherapy, before your surgery. During this time, and then for up to two years after your surgery, you will either take simvastatin tablets daily or just continue with your usual care. You won't know if you're taking simvastatin or not, as this helps make the study fair. You will have regular appointments for check-ups and tests, just like you would with standard cancer treatment, to see how you are responding and if the cancer stays away. The total duration of active involvement with the study medication could be up to two years, but you would have follow-up appointments to track your health for longer.

Potential risks and benefits

Taking part in this study could potentially offer an improved chance of your cancer responding better to treatment and staying away for longer, simply by adding a well-known and generally safe medication. However, as with any medical study, there are always potential risks; for simvastatin, these are usually mild but can include muscle pain or, rarely, liver issues, which will be monitored closely. Remember, you have the right to withdraw from the study at any time, for any reason, and this will not affect the quality of your future medical care.

Locations (1)

McGill University Health Center
Verified postcode
Montreal, Canada

Common questions

What is simvastatin?

Simvastatin is a common medicine usually prescribed to lower cholesterol levels in the blood. It's affordable and many people take it safely.

What does 'standard chemotherapy' mean?

This refers to the usual combination of cancer drugs doctors would give you for your type of cancer before surgery, often with drugs like FLOT.

Why is this study important?

Cancers of the food pipe and stomach are hard to treat. This study hopes to find a simple, safe, and affordable way to make current treatments more effective and improve patient outcomes.

Will I know if I'm taking simvastatin?

To keep the study fair, you won't know whether you're taking simvastatin or a dummy pill. This is called a 'blinded' study.

What if I get side effects from simvastatin?

The study team will monitor you closely for any side effects. If you experience any, you should report them to your doctors immediately.

How to find out more

Lorenzo Edwin Ferri, MD, PhD

lorenzo.ferri@mcgill.ca 514-934-1934 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.