Total Intravenous Anesthesia and Recurrence Free Survival

NCT04513808 | Recruiting Phase 3

• 1 other identifier: VICTORY
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  Patients who did not experience cancer recurrence and/or death.

  4 years

Secondary Outcomes (3)

• ICU duration

  From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months

• Hospital duration

  Up to 100 months

• QoR-15

  2 days

Study Arms (2)

Propofol-based total intravenous anesthesia

ACTIVE COMPARATOR

Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.

Drug: Propofol-based total intravenous anesthesia

Sevoflurane intravenous anesthesia

ACTIVE COMPARATOR

Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary

Drug: Sevoflurane intravenous anesthesia

Interventions

Propofol-based total intravenous anesthesia DRUG

Propofol-based total intravenous anesthesia, titrated to clinical need.

Also known as: Propofol

Propofol-based total intravenous anesthesia

Sevoflurane intravenous anesthesia DRUG

Sevoflurane intravenous anesthesia, titrated to clinical need.

Also known as: Sevoflurane

Sevoflurane intravenous anesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
• Scheduled for potentially curative esophageal cancer surgery.
• Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.

You may not qualify if:

• Previous surgery for esophageal cancer (except diagnostic biopsies) Age \<18 or \>85 years old.
• ASA Physical Status ≥4.
• Any contraindication to propofol or sevoflurane.
• Other cancer not believed by the attending surgeon to be in long-term remission.
• Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Shanhai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Yuwei Oui, MD

  Shahai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel I Sessler, MD

CONTACT

216-870-2620; DS@CCF.org

Fabio Rodriquez Patarroyo, MD

CONTACT

‭(216) 444-9674‬; Rodrigf3@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: August 14, 2020
• Study Start: August 15, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years after publication of the main paper.
• Access Criteria: Contact investigators.

Locations

CN (1)