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General Anaesthetic

Anesthesia for Cancer

Phase 3
Recruiting
Led By Bernhard Riedel, MB.ChB
Research Sponsored by Peter MacCallum Cancer Centre, Australia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgery expected to last ≥2 hours and expected to require ≥2 nights hospital stay
Scheduled to receive elective, surgical resection with curative intent
Must not have
Patient with significant liver disease (with elevated International Normalised Ratio (INR) or bilirubin and/or low albumin; i.e. Childs-Pugh Score >Class A)
Patient at personal or familial risk of malignant hyperthermia or porphyria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 3 years from participant index surgery date
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether IV or inhaled anesthesia is better for patients with colorectal or non-small-cell lung cancer, with or without lidocaine.

Who is the study for?
The VAPOR-C trial is for adults with Stage I-III colorectal or non-small cell lung cancer (NSCLC) who are scheduled for elective surgery that will last at least 2 hours and require a hospital stay of 2+ nights. Participants must be able to follow the study plan and have an ASA score of 1-3. Exclusions include weight under 45kg, significant liver disease, recent other cancers, certain drug use, and allergies to trial drugs.
What is being tested?
This study compares IV anesthesia (propofol) with inhaled anesthesia (sevoflurane), along with the addition or absence of lidocaine. The goal is to see how these different anesthesia methods affect cancer-free survival time after surgery in patients with colorectal or NSCLC.
What are the potential side effects?
Potential side effects may include typical reactions to anesthesia such as nausea, vomiting, sore throat, confusion post-surgery; propofol might cause low blood pressure or pain at injection site; sevoflurane can lead to coughing or breath-holding during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery is expected to last 2 or more hours and will require a hospital stay of 2 or more nights.
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I am scheduled for surgery to remove my cancer with the goal of curing it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe liver disease.
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I or my family have a history of malignant hyperthermia or porphyria.
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I weigh less than 45kg.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 3 years from participant index surgery date
This trial's timeline: 3 weeks for screening, Varies for treatment, and until 3 years from participant index surgery date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease
Disease
Secondary study objectives
Lidocaine
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Propofol
+11 more
Other study objectives
Comparison of return to intended oncological treatment (RIOT) with intravenous lidocaine versus no lidocaine
Comparison of return to intended oncological treatment (RIOT) with propofol-TIVA versus sevoflurane
Blood Gas Analysis
+2 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: AActive Control2 Interventions
Sevoflurane + intravenous lidocaine
Group II: BActive Control1 Intervention
Sevoflurane
Group III: CActive Control2 Interventions
Propofol TIVA + intravenous lidocaine
Group IV: DActive Control1 Intervention
Propofol TIVA

Find a Location

Who is running the clinical trial?

Peter MacCallum Cancer Centre, AustraliaLead Sponsor
99 Previous Clinical Trials
23,288 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
166 Previous Clinical Trials
473,206 Total Patients Enrolled
Australian and New Zealand College of AnaesthetistsOTHER
5 Previous Clinical Trials
8,320 Total Patients Enrolled
Victorian Comprehensive Cancer CentreUNKNOWN
Bernhard Riedel, MB.ChBPrincipal InvestigatorPeter MacCallum Cancer Centre, Australia

Media Library

Propofol (General Anaesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04316013 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: A, B, C, D
Non-Small Cell Lung Cancer Clinical Trial 2023: Propofol Highlights & Side Effects. Trial Name: NCT04316013 — Phase 3
Propofol (General Anaesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04316013 — Phase 3
~1392 spots leftby Dec 2027
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