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

NCT07625930 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Adenocarcinoma

Interventions

DRUG

FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)

Standard of care neoadjuvant FLOT

DRUG

Simvastatin

Investigational drug added to standard of care FLOT or FLOT+D

DRUG

Durvalumab

Standard of care Durvalumab added to FLOT regimen.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2029-04-30
Completion
2031-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07625930 on ClinicalTrials.gov