Gastroesophageal AdenocarcinomaPhase 2RESTAGENCT07625930
RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial
A Phase 2 study testing FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel), Simvastatin and Durvalumab in people with Gastroesophageal Adenocarcinoma, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel), Simvastatin and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Apr 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Prior esophageal or gastric malignancy.
- 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.
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- 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.
- Pregnant and breastfeeding women.
- Unwillingness to undergo per-protocol investigations or treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McGill University Health Center
Montreal
Lorenzo Edwin Ferri, MD, PhD, 514-934-1934 ext. 42835, lorenzo.ferri@mcgill.ca
About this study
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
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.
Read more
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.
- Conditions
- Gastroesophageal Adenocarcinoma
- Being tested
- FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel), Simvastatin, Durvalumab
- Keywords
- Esophageal cancer, Gastroesophageal junction cancer, Statin, Gastroesophageal Adenocarcinoma
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)Drug
Standard of care neoadjuvant FLOT
SimvastatinDrug
Investigational drug added to standard of care FLOT or FLOT+D
DurvalumabDrug
Standard of care Durvalumab added to FLOT regimen.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | SOC neoadjuvant FLOT (or FLOT-D) Receives: Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel); Drug: Durvalumab |
| Experimental | Experimental | SOC neoadjuvant FLOT (or FLOT-D) + simvastatin Receives: Drug: FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel); Drug: Simvastatin; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR
Major Pathological Response
Measured: From enrolment to surgical pathology assessment, 16 weeks
Secondary outcomes (2)
Statin-enhanced toxicity of standard-of-care regimen, specifically grade 3 or 4 adverse events
Statin-enhanced toxicity of standard-of-care regimen, specifically grade 3 or 4 adverse events, as per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, warranting dosage modification or stoppage of interventional drug or chemotherapy. CTCAE grading is from 1 to 5, while grade 1 is the least severe (mild) and grade 5 is the most severe (death).
Measured: Start of neoadjuvant therapy to the end of adjuvant therapy (weeks 2-28)
2-year EFS
2-year event-free-survival (EFS), defined as elapsed time from date of randomization to date of recurrence (local or distant) or death, occurring after resection
Measured: Elapsed time from date of randomization to date of recurrence or death, within 2 years from resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Ferri, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625930
- Sponsor's protocol ID
- THOR-ESO-2026-01
- Acronym
- RESTAGE
- Status last verified
- Jul 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided