Under construction – not a live service
Sign in
Not yet taking people in CanadaPhase 2

Simvastatin added to chemotherapy before and after surgery for gastroesophageal cancer

Tests simvastatin alongside standard cancer treatment in adults with gastroesophageal adenocarcinoma.

Key facts

Who runs it
McGill University Health Centre/Research Institute of the McGill University Health Centre
Where
Montreal, CanadaSee the site
Trial code
Registry title
RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial
Status
Not yet recruiting
Phase
Phase 2
People taking part
184 people, planned
Starts
Jan 2027
Expected to end
Apr 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)
  • Simvastatin
  • Durvalumab
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with gastroesophageal adenocarcinoma that is locally advanced but may be removed by surgery. They must be able to have chemotherapy before surgery.

Age
18 years or older
Sex
All sexes can join
Disease stage
Adenocarcinoma or poorly differentiated carcinoma of the esophagus or the junction of esophagus and stomach (EGJ). Locally advanced disease, stage IIA, IIB, III or IVA (T1-4a N2-3). The surgical team must judge the tumour potentially resectable, with no spread to distant organs.
Earlier treatment
Must be able to have standard chemotherapy before and after surgery (FLOT with or without durvalumab). Cannot be on cholesterol-lowering medicine such as statins, fibrates, ezetimibe or PCSK9 inhibitors; these people are offered an observational arm instead.

Main reasons for not taking part

  • Earlier cancer of the esophagus or stomach
  • Allergy to simvastatin, atorvastatin or similar compounds
  • Liver or kidney problems (ALT or creatinine more than 3 times the upper limit of normal)
  • Taking strong CYP3A4-inhibitor medicines, such as ketoconazole, erythromycin or cyclosporine
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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
  • ECOG performance status < 2

Who cannot take part

  • Prior esophageal or gastric malignancy
  • Ongoing cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors), in which case the patient is offered enrollment in the observational arm
  • Concurrent medication with potent CYP3A4-inhibitors, e.g. ketokonazole, erythromycin, gemfibrozil, cyclosporine, or danazol
  • History of allergic reactions to simvastatin or atorvastatin or similar chemical or biological compounds
  • 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)
  • 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
  • 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)
  • Pregnant and breastfeeding women
  • Unwillingness to undergo per-protocol investigations or treatments

Where in Canada

  • McGill University Health CenterMontreal, CanadaContact: Lorenzo Edwin Ferri, MD, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • ControlExisting treatment, for comparison

    SOC neoadjuvant FLOT (or FLOT-D)

    Treatment: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) and Durvalumab

  • ExperimentalTreatment being tested

    SOC neoadjuvant FLOT (or FLOT-D) + simvastatin

    Treatment: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel), Simvastatin, and Durvalumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma
Plain-language title
Simvastatin added to chemotherapy before and after surgery for gastroesophageal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 July 2026