Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colonic Cancer
- Non -Small Cell Lung Cancer
- Rectal Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an event-driven, international multicentre, randomised controlled trial with a 2x2 factorial design. Patients with stage I-III colorectal cancer or stage I-IIIa NSCLC are eligible and will be randomised in the ratio of 1:1:1:1 using permuted block randomisation with stratification by cancer type (Colon, Rectal or NSCLC), preoperative cancer risk stage (Colon: low [stage I & II] and high [stage III] risk; Rectal: low [stage I] and high [stage II & III] risk; NSCLC: low [stage I] and high [stage II & IIIa] risk) and by site to receive either 1) sevoflurane maintenance anaesthesia and lidocaine infusion or 2) sevoflurane maintenance anaesthesia and placebo; or 3), propofol maintenance anaesthesia and lidocaine infusion or 4), propofol maintenance anaesthesia and placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The propofol-TIVA/sevoflurane element of each arm will have a single blind (patient blinded), as the administering anesthesiologist cannot be blinded to allocation. The lidocaine/placebo element of each ARM will be blinded to the patient, and all members of the VAPOR-C research team. The anaesthetic team caring for the patient will not be blinded to the lidocaine/placebo element of the randomisation ARM only.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
VAPOR-C is a pragmatic, event-driven, randomised controlled trial, with a blinded 2x2 factorial design for sevoflurane/propofol and for intravenous lidocaine/placebo administration. This trial is designed to test for superiority in disease free survival (DFS) of propofol (total intravenous anaehesia...
VAPOR-C is a pragmatic, event-driven, randomised controlled trial, with a blinded 2x2 factorial design for sevoflurane/propofol and for intravenous lidocaine/placebo administration. This trial is designed to test for superiority in disease free survival (DFS) of propofol (total intravenous anaehesia -TIVA) over sevoflurane (inhalational volatile anaesthesia) and intravenous lidocaine over placebo 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 5,736 patients in Australia, New Zealand, Canada, United States and Europe.
Tracking Information
- NCT #
- NCT04316013
- Collaborators
- National Health & Medical Research Council of Australia (NH&MRC)
- The Australian and New Zealand College of Anaesthetists (ANZCA)
- Victorian Comprehensive Cancer Centre
- Investigators
- Principal Investigator: Bernhard Riedel, MB.ChB Peter MacCallum Cancer Centre, Australia
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