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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 3 years from participant index surgery date
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My surgery is expected to last 2 or more hours and will require a hospital stay of 2 or more nights.
Select...
I am scheduled for surgery to remove my cancer with the goal of curing it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until 3 years from participant index surgery date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 3 years from participant index surgery date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Disease
Secondary outcome measures
Lidocaine
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Propofol
+11 moreOther outcome measures
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 moreTrial 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
95 Previous Clinical Trials
22,007 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
471,637 Total Patients Enrolled
Australian and New Zealand College of AnaesthetistsOTHER
5 Previous Clinical Trials
8,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe liver disease.I haven't taken specific strong antibiotics, antifungals, antivirals, antidepressants, or other listed drugs in the last 3 days.I or my family have a history of malignant hyperthermia or porphyria.I am 18 years old or older.My colorectal cancer or NSCLC is in an early to mid-stage, confirmed by tests or suspected through scans.I weigh less than 45kg.My surgery is expected to last 2 or more hours and will require a hospital stay of 2 or more nights.I am scheduled for surgery to remove my cancer with the goal of curing it.My cancer has spread to distant parts of my body.I had cancer before, but it was treated and is unlikely to come back.
Research Study Groups:
This trial has the following groups:- Group 1: A
- Group 2: B
- Group 3: C
- Group 4: D
Awards:
This trial has 4 awards, including:- 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.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is C deadly for human beings if ingested?
"C has received a score of 3 from our team at Power. This is based on the fact that C is in Phase 3 trials, which suggests that not only is there some evidence of efficacy, but also that multiple rounds of data support its safety."
Answered by AI
For what reasons is C often given to patients?
"C is a medication with various applications, such as treating cervical syndrome and minor burns. It can also be used in cases of general anesthesia or transplantation surgery."
Answered by AI
Are there any other ongoing or previous studies that have looked at C?
"C was first observed in a clinical setting at Keck Medical Center of USC. In the 16 years since, there have been 19632 completed trials. Right now, 221 studies are ongoing with a large proportion taking place in Pittsburgh, Pennsylvania."
Answered by AI
What is the largest number of people who are able to take part in this experiment?
"In order to run this trial smoothly, we need 5736 individuals that fit the bill in terms of our inclusion criteria. If you are interested in participating and live near either University of Pittsburgh Medical Center or The University of Texas MD Anderson Cancer Centre, please reach out!"
Answered by AI
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