Volatile anaesthesia and perioperative outcomes related to cancer

Volatile anaesthesia and perioperative outcomes related to cancer

 

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

Preclinical and retrospective clinical research suggests that propofol-TIVA may associate with improved disease-free survival and overall survival when compared with inhalational anaesthesia for cancer surgery. VAPOR-C will explore the impact of anaesthetic technique on disease-free survival after cancer surgery. The target recruitment is 3500 participants with stage 1-3 (curative intent) colorectal cancer or non-small-cell lung cancer scheduled for surgical resection. For all the latest updates on VAPOR-C, follow @VAPOR_C on Twitter. 

Principal investigator

Professor Bernhard Reidel at University of Melbourne and Peter MacCallum Cancer Centre

Progress

The VAPOR-C Study has entered a recruitment hold to allow for a major protocol amendment. There are currently 38 sites already recruiting or in the late phases of startup across Australia, New Zealand, the United States, Canada, and the United Kingdom. Thank you everyone for your ongoing support. To date, 254 patients have been enrolled in the trial. 

Trial summary

Surgery is a primary treatment for more than 60 per cent of patients with cancer, with consequent exposure to anaesthesia. Alarmingly, retrospective clinical cohorts suggest that general anaesthesia with inhaled volatiles associates with reduced cancer-free and overall survival when compared with total intravenous anaesthesia (TIVA) with propofol.
Our preclinical mouse models confirmed these findings and also demonstrate that intravenous lidocaine reduces cancer progression. Factors may include the pro-inflammatory, pro-angiogenic, pro-survival, and immunosuppressive properties of volatile anaesthesia. Our survey of Australian practice found that more than 80 per cent of anaesthetists routinely use inhaled anaesthesia and less than 50 per cent of respondents felt that anaesthetic technique impacts cancer outcomes. This lack of clinical consensus on optimal anaesthesia for cancer surgery reflects the urgent need for a definitive randomised clinical trial. This definitive study will inform international anaesthesia guidelines and the findings rapidly translated as these drugs are generic, cheap, and available worldwide. We anticipate that this study will have a dramatic effect on individual wellbeing, population health, and health care costs.

Study design
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 and aims to study two primary hypotheses in patients undergoing colorectal or lung cancer surgery.

Primary endpoints
Propofol-TIVA and lidocaine increases disease-free survival compared with volatile anaesthesia.

Secondary endpoints
Will explore impact of anaesthesia on postoperative complications, quality of recovery, return to adjuvant therapies and incidence of chronic pain.

Sample size
An estimated total sample size of 3500 (875 per group) patients is required to achieve 850 events (failed disease-free survival within three years).

Study duration
Four years.

Funding

The Australian National Health and Medical Research Council and the Victorian Comprehensive Cancer Centre. 

Participating hospitals

Australian Hospitals
Alfred Health
Austin Hospital
Ballarat Health Services
Eastern Health - Box Hill Hospital
Gold Coast University Hospital
Goulburn Valley Health
Mackay Base Hospital
Peter MacCallum Cancer Centre
Prince of Wales Hospital
Princess Alexandra Hospital
Redcliffe Hospital
Rockhampton Hospital
Royal Adelaide Hospital
Royal Brisbane and Women's Hospital
Royal Melbourne Hospital
Royal Prince Alfred
St Vincent’s Melbourne
Wangaratta Base Hospital
Western Health - Footscray
New Zealand Hospitals
Auckland City Hospital
North Shore Hospital
International hospitals
Cleveland Clinic
MD Anderson Centre
University of Pittsburgh
Stony Brook Hospital NY
Canada
Alberta Health Services, AB

Trial registration

ClinicalTrials.gov Identifier: NCT04316013

Per patient payment

$A1000 per patient (+$A100 for MINS Sub-study participants) and a site start up payment of $A750.

How to get involved

For further information about this study, please contact the VAPOR-C Project Manager, Kim Coleman by email.

For more information

Last updated 15:03 19.12.2023