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

Study acronym: RESTAGE
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: SOC neoadjuvant FLOT (or FLOT-D) (Drug), SOC neoadjuvant FLOT (or FLOT-D) + simvastatin (Drug) to Durvalumab (Drug), FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) (Drug), Simvastatin (Drug)
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07625930
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
(from sponsor)		 Gastroesophageal Adenocarcinoma
Related terms Esophageal Neoplasms
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov