A Phase 3 interventional study of Sevoflurane and Propofol in Colonic Cancer, Rectal Cancer and Non Small Cell Lung Cancer, sponsored by Peter MacCallum Cancer Centre, Australia. Terminated at 27 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Peter MacCallum Cancer Centre, Australia · Phase 3, Interventional, and Other
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 254 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Peter MacCallum Cancer Centre, Australia is the lead sponsor of 80 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sevoflurane + intravenous lidocaine
Drug: Sevoflurane · Drug: Lidocaine IV
Sevoflurane
Drug: Sevoflurane
Propofol TIVA + intravenous lidocaine
Drug: Propofol · Drug: Lidocaine IV
Propofol TIVA
Drug: Propofol
Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
Intravenous anaesthetic used for induction and maintenance of anaesthesia
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.
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane
The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms.
Time frame: Until 3 years from participant index surgery date
Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine
The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms.
Time frame: Until 3 years from participant index surgery date
Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane
The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.
Time frame: Until 3 years from participant index surgery date
Days alive and at home with propofol-TIVA versus sevoflurane
Data will be collected at thirty days post surgery regarding date of discharge from hospital and survival status. This is then used to calculate number of days alive and at home (i.e. out of hospital) and compare across arms.
Time frame: 30 days post surgery
Overall survival with intravenous lidocaine versus no lidocaine
The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.
Time frame: Until 3 years from participant index surgery date
Days alive and at home with intravenous lidocaine versus no lidocaine
Data will be collected at thirty days post surgery regarding date of discharge from hospital and survival status. This is then used to calculate number of days alive and at home (i.e. out of hospital) and compare across arms.
Time frame: 30 days post surgery
Comparison of post-operative complications with propofol-TIVA versus sevoflurane
Short term postoperative morbidity assessed by the Post Operative Morbidity Scale (POMS) with Clavien-Dindo severity grading. POMS is an 18-item tool that addresses nine domains of morbidity relevant to the post-surgical patient . The severity in each POMS domain will then be graded according to the Clavien-Dindo Classification on the basis of treatment applied to correct each respective complication , and captures complications within 5 grades.
Time frame: 5 days post surgery or at discharge if earlier
Comparison of post-operative complications with intravenous lidocaine versus no lidocaine
Short term postoperative morbidity assessed by the Post Operative Morbidity Scale (POMS) with Clavien-Dindo severity grading. POMS is an 18-item tool that addresses nine domains of morbidity relevant to the post-surgical patient . The severity in each POMS domain will then be graded according to the Clavien-Dindo Classification on the basis of treatment applied to correct each respective complication , and captures complications within 5 grades.
Time frame: 5 days post surgery or at discharge if earlier
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Pain measured using the Brief Pain Inventory Short Form. Patient reported pain on a scale of 0 to 10 where 0 is no pain and 10 is worst pain. Pain measured using the Neuropathic Pain Questionnaire. Patient reported neuropathic pain on a scale of 0 to 100 where 0 is no pain and 100 is worst pain.
Time frame: At 90 days and 12 months post surgery
Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine
Pain measured using the Brief Pain Inventory Short Form. Patient reported pain on a scale of 0 to 10 where 0 is no pain and 10 is worst pain. Pain measured using the Neuropathic Pain Questionnaire. Patient reported neuropathic pain on a scale of 0 to 100 where 0 is no pain and 100 is worst pain.
Time frame: At 90 days and 12 months post surgery
Safety profile of propofol-TIVA versus sevoflurane
Toxicities measured using CTCAE V 5 .0
Time frame: during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Safety Profile intravenous lidocaine versus no lidocaine
Toxicities measured using CTCAE V 5 .0
Time frame: during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Concomitant medication use with propofol-TIVA versus sevoflurane
From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded
Time frame: 5 days post anaesthesia
Concomitant medications use with intravenous lidocaine versus no lidocaine
From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded
Time frame: 5 days post anaesthesia
Health utility with propofol-TIVA versus sevoflurane
The EQ-5D-5L is a standardised instrument for use as a measure of health outcome and is applicable to a wide range of health conditions and treatments. This five item scale covers the following dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with each dimension having five levels (5L). The use of the EQ-5D-5L will enable utility valuations to be estimated for health states experienced.
Time frame: At 30 days, 90 days and every 12 months post surgery up to 3 years
Health utility with intravenous lidocaine versus no lidocaine
The EQ-5D-5L is a standardised instrument for use as a measure of health outcome and is applicable to a wide range of health conditions and treatments. This five item scale covers the following dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with each dimension having five levels (5L). The use of the EQ-5D-5L will enable utility valuations to be estimated for health states experienced
Time frame: At 30 days, 90 days and every 12 months post surgery up to 3 years
Comparison of return to intended oncological treatment (RIOT) with propofol-TIVA versus sevoflurane
Data will be collected post surgery regarding post treatment adjuvant therapy given according to plan. A comparison will be made between number of participants receiving post surgery oncological treatment as planned and the number of patients deviating from the plan in each arm of the study.
Time frame: At 90 days and 12 months post surgery
Comparison of return to intended oncological treatment (RIOT) with intravenous lidocaine versus no lidocaine
Data will be collected post surgery regarding post treatment adjuvant therapy given according to plan. A comparison will be made between number of participants receiving post surgery oncological treatment as planned and the number of patients deviating from the plan in each arm of the study.
Time frame: At 90 days and 12 months post surgery
Correlative blood studies
Inflammatory markers - Neutrophil to lymphocyte ratio (NLR), Platelet to lymphocyte ratio (PLR), C-reactive protein (CRP) Circulating tumour deoxyribonucleic acid (ctDNA), DNA/RNA, Circulating tumour cells (CTCs), immune profile using flow cytometry and plasma for cytokines These are exploratory transnational research outcomes levels of these biomarkers will be measured over the course of the study and analysed for correlation the study outcomes.
Time frame: Preop, Day 1, 3 and 5 (if still an inpatient) and at recurrence
Correlative breath biopsy studies
To characterise the effect of anaesthetic agents on perioperative inflammatory changes will measure Targeted Volatile Organic Compounds of the eicosanoid pathway by sampling patients breath (breath biopsy) to monitor inflammatory changes within the pulmonary compartment.
Time frame: Preop, Day 1, 3 and 5 (if still an inpatient) and at recurrence
MINS Substudy
At sites who agree to participate: Blood Specimens and 12-Lead ECG - 12 Lead ECGS will be done and blood specimens collected to measure Troponin levels at baseline, Day 1 and Day 2 post op. Assessment of the predefined diagnostic criteria for MINS and perioperative myocardial infarction on Day 5 or Discharge if earlier Assessment of predefined diagnostic criteria for MINS and myocardial infarction at 30 days post op.
Time frame: Day 0 to day 30
Plan to share: No
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Peter MacCallum Cancer Centre, Australia