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About Vapor-C

Summary

Cancer is the leading cause of death in developing nations and has surpassed cardiovascular disease as the leading cause of death in developed nations. While surgery remains the primary treatment for solid tumours, metastatic recurrence occurs in many patients and is responsible for more than 90% of deaths in people with cancer. Studies show that perioperative (surgical and anaesthetic) factors may impact metastatic recurrence post-surgery.

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The act of surgery causes significant biological perturbation, stress, inflammation and suppression of cell-mediated immunity that can lead to the proliferation of residual cancer cells post-surgery. Certain anaesthesia drugs may favorably alter the inflammation and stress response to cancer surgery, leading to improved outcomes. For example in a cohort study, findings suggested that general anaesthesia delivered by total intravenous anaesthesia (TIVA) with propofol is associated with improved survival outcomes in comparison to anaesthesia by inhaled volatiles. Pre-clinical mouse models show that an infusion of the local anaesthesia drug lidocaine reduces inflammation and recurrence. These two drugs (propofol and lidocaine) will be studied in the VAPOR-C trial.

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The VAPOR-C trial is an international, multi-centre, pragmatic, event-driven, randomised controlled trial investigating the effects of sevoflurane or propofol based general anaesthesia, as well as intravenous lidocaine  administered during surgery and their effects on outcomes after colorectal and lung cancer surgery.

This website provides information and updates on the trial and participating sites. If you are interested in running this trial at your site, please contact the research team using the form below.

Endorsed by

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European Society of Anaesthesiology Research Group

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  • Status
    Open/Recruiting
  • Design
    This is an event-driven, randomised control trial with a 2x2 factorial design. Subjects are randomised in the ratio of 1:1:1:1 using permuted block randomisation stratified by cancer type and by treating centre to receive either 1) sevoflurane maintenance anaesthesia and lidocaine infusion or 2) sevoflurane maintenance anaesthesia; or 3), propofol maintenance anaesthesia and lidocaine infusion or 4), propofol maintenance.
  • Primary Objectives
    1. To determine if propofol-TIVA increases Disease Free Survival (DFS) compared with sevoflurane 2. To determine if intravenous lidocaine increases DFS compared with no lidocaine
  • Secondary Objectives
    The secondary objectives for this study are: To compare propofol-TIVA versus sevoflurane in regards to: Overall Survival Days Alive and out of Hospital at 30 days To compare intravenous lidocaine versus no lidocaine in regards to: Overall Survival Chronic Post Surgical Pain at 90 days Days Alive and out of Hospital at 30 days To compare propofol-TIVA versus sevoflurane as well as intravenous lidocaine versus no lidocaine in regard to: Post-operative complications Functional capacity Acute post-operative pain Chronic post-surgical pain (at 90 days and 12 months) Adverse events during surgery until discharge from Post Anaesthetic Care Unit (PACU) or to within the first 4 hours of intensive care unit (ICU) admission Health utility
  • Population
    We expect to recruit 3,500 subjects across approximately 40 sites.
  • Eligibility Criteria
    Key Eligibility criteria Male or female patients aged 18 years or older Patients with Stage I-III colorectal cancer or Stage I-IIIa non-small cell lung carcinoma Patients receiving elective, surgical resection with curative intent Surgery expected to last ≥2 hours and expected to require ≥2 nights hospital stay
  • Duration
    Planned recruitment duration is 4 years and patients will be followed up every year after surgery for up to three years. The expected total study duration is up to 7 years.
  • VAPOR-C Feasibility Study
    In preparation for this large, international RCT, we undertook a randomised, double-blinded, feasibility and pilot study of propofol-TIVA or volatile-based maintenance anaesthesia during cancer resection surgery at four tertiary hospitals in Australia and the United States. Patients were randomised on day of surgery to receive either TIVA or volatile-based maintenance anaesthesia. We demonstrated feasibility of the study protocol with a recruitment rate of 67% and a 99% adherence to randomised treatment. . As part of this feasibility study, exploratory sub-studies were undertaken to further investigate the impact of anaesthetic technique on perioperative stress response and postoperative outcome and a biorepository of over 450 patient blood samples was established from colorectal, lung, prostate, melanoma and breast cancer surgical patients. Novel work is being undertaken in in collaboration with senior scientists across the University of Melbourne (Professor Fred Hollande) and Monash University (A/Professor Erica Sloan) to interrogate the inflammatory-immune response to anaesthesia and the potential impact of surgery on tumour cell proliferation and metastasis. . The feasibility and pre-clinical studies were developed and completed with the assistance and support of: MCATS and The University of Melbourne ANZCA and ANZCA CTN Monash University Drug Discovery Biology Peter MacCallum Cancer Centre Victorian Comprehensive Cancer Centre (VCCC)
  • Funding Body Acknowledgments
    This study has been funded by grants and in-kind support from the following: National Health and Medical Research Council Victorian Comprehensive Cancer Centre The University of Melbourne Australian and New Zealand College of Anaesthetists
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