NCT04316013

Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

VAPOR-C is a randomised study of the impact of IV versus inhaled anaesthesia (propofol versus sevoflurane) and lidocaine versus no lidocaine on duration of disease free survival inpatients with either colorectal or non small cell lung cancer.

Detailed description

VAPOR-C is a pragmatic, event-driven, randomised controlled trial, with a single blind 2x2 factorial design for sevoflurane/propofol and for intravenous lidocaine infusion / no lidocaine infusion. This trial is designed to test for superiority in disease free survival (DFS) of propofol (total intravenous anaesthesia -TIVA) over sevoflurane (inhalational volatile anaesthesia) and intravenous lidocaine over no lidocaine in patients undergoing surgery for colorectal or non small cell lung cancer (NSCLC). The combination of two cancer types will help address the need to demonstrate the effects of anaesthetic technique across cancers to inform generalisable anaesthesia guidelines. Both NSCLC and colorectal cancer are important for this study due to high incidence rate, many longer-term survivors, and importantly the high risk of local or distant recurrence despite complete surgical resection. In addition, the study will collect additional data in a nested cohort related to the exploratory objectives. The study aims to recruit 3,500 patients in Australia, New Zealand, Canada, United States and Europe.

Conditions

• Colonic Cancer
• Rectal Cancer
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sevoflurane	Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
DRUG	Propofol	Intravenous anaesthetic used for induction and maintenance of anaesthesia
DRUG	Lidocaine IV	1.5mg/kg loading dose over 20 minutes, followed by an infusion of 2mg/kg/hr up to 4 hours and 1.5mg/kg/hour thereafter. Bolus and maintenance dosages of lidocaine will be per actual body weight and capped at a maximum of 100 kg.

Timeline

• Start date: 2020-07-31
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2020-03-20
• Last updated: 2025-03-14

Locations

27 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study