Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04316013
Registration number
NCT04316013
Ethics application status
Date submitted
22/01/2020
Date registered
20/03/2020
Date last updated
23/03/2023
Titles & IDs
Public title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial
Query!
Scientific title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial
Query!
Secondary ID [1]
0
0
18/044
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Colonic Cancer
0
0
Query!
Rectal Cancer
0
0
Query!
Non Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Sevoflurane
Treatment: Drugs - Propofol
Treatment: Drugs - Lidocaine IV
Active Comparator: A - Sevoflurane + intravenous lidocaine
Active Comparator: B - Sevoflurane
Active Comparator: C - Propofol TIVA + intravenous lidocaine
Active Comparator: D - Propofol TIVA
Treatment: Drugs: Sevoflurane
Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
Treatment: Drugs: Propofol
Intravenous anaesthetic used for induction and maintenance of anaesthesia
Treatment: Drugs: Lidocaine IV
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Until 3 years from participant index surgery date
Query!
Primary outcome [2]
0
0
Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Until 3 years from participant index surgery date
Query!
Secondary outcome [1]
0
0
Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane
Query!
Assessment method [1]
0
0
The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.
Query!
Timepoint [1]
0
0
Until 3 years from participant index surgery date
Query!
Secondary outcome [2]
0
0
Days alive and at home with propofol-TIVA versus sevoflurane
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
30 days post surgery
Query!
Secondary outcome [3]
0
0
Overall survival with intravenous lidocaine versus no lidocaine
Query!
Assessment method [3]
0
0
The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.
Query!
Timepoint [3]
0
0
Until 3 years from participant index surgery date
Query!
Secondary outcome [4]
0
0
Days alive and at home with intravenous lidocaine versus no lidocaine
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
30 days post surgery
Query!
Secondary outcome [5]
0
0
Comparison of post-operative complications with propofol-TIVA versus sevoflurane
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
5 days post surgery or at discharge if earlier
Query!
Secondary outcome [6]
0
0
Comparison of post-operative complications with intravenous lidocaine versus no lidocaine
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
5 days post surgery or at discharge if earlier
Query!
Secondary outcome [7]
0
0
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
At 90 days and 12 months post surgery
Query!
Secondary outcome [8]
0
0
Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
At 90 days and 12 months post surgery
Query!
Secondary outcome [9]
0
0
Safety profile of propofol-TIVA versus sevoflurane
Query!
Assessment method [9]
0
0
Toxicities measured using CTCAE V 5 .0
Query!
Timepoint [9]
0
0
during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Query!
Secondary outcome [10]
0
0
Safety Profile intravenous lidocaine versus no lidocaine
Query!
Assessment method [10]
0
0
Toxicities measured using CTCAE V 5 .0
Query!
Timepoint [10]
0
0
during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Query!
Secondary outcome [11]
0
0
Concomitant medication use with propofol-TIVA versus sevoflurane
Query!
Assessment method [11]
0
0
From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded
Query!
Timepoint [11]
0
0
5 days post anaesthesia
Query!
Secondary outcome [12]
0
0
Concomitant medications use with intravenous lidocaine versus no lidocaine
Query!
Assessment method [12]
0
0
From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded
Query!
Timepoint [12]
0
0
5 days post anaesthesia
Query!
Secondary outcome [13]
0
0
Health utility with propofol-TIVA versus sevoflurane
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
At 30 days, 90 days and every 12 months post surgery up to 3 years
Query!
Secondary outcome [14]
0
0
Health utility with intravenous lidocaine versus no lidocaine
Query!
Assessment method [14]
0
0
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
Query!
Timepoint [14]
0
0
At 30 days, 90 days and every 12 months post surgery up to 3 years
Query!
Eligibility
Key inclusion criteria
1. Male or female patients aged 18 years or older at screening
2. Has provided written informed consent for the trial
3. Patient with American Joint committee on Cancer (AJCC) 8th edition Stage I-III
colorectal cancer or Stage I-IIIa NSCLC, as confirmed by histological or cytological
diagnosis. In cases where a histological diagnosis is not possible, suspected
diagnosis through imaging techniques is acceptable.
4. Patient has an American Society of Anaesthesiologists (ASA) score of 1 to 3
5. Scheduled to receive elective, surgical resection with curative intent
6. Surgery expected to last =2 hours and expected to require =2 nights hospital stay
7. Able to comply with protocol requirements and follow-up procedures
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Confirmed or suspected allergy to propofol, sevoflurane or intravenous lidocaine
2. Patient with significant liver disease (with elevated International Normalised Ratio
(INR) or bilirubin and/or low albumin; i.e. Childs-Pugh Score >Class A;
3. Patient at personal or familial risk of malignant hyperthermia or porphyria
4. Patient with a history of other malignancies within the past 5 years. However,
patients with malignancies managed with curative therapy and considered to be at low
risk of recurrence such as treated skin basal cell carcinoma, squamous cell carcinoma,
malignant melanoma =1.0mm without ulceration, localised thyroid cancer, cervical
carcinoma in situ or prior malignancies with high likelihood of cure (e.g. low grade
prostate and breast cancer) may be included in the study
5. Patient has distant metastases
6. Patient with an actual body weight less than 45kg
7. Patients taking the following drugs that are moderate-strong inhibitors of the CYP1A2
and CYP3A4 metabolic pathways within 72 hours prior to surgery: Antibiotics - 'mycin'
class: Clarithromycin, Telithromycin, Azithromycin, Erythromycin Antibiotics -
'floxacin' class Ciprofloxacin (exception: can be used preoperatively within a bowel
prep regime), Norfloxacin, Levofloxacin, Sparfloxacin Antibiotics - other:
Chloramphenicol, Isoniazid Antifungals: Fluconazole, Itraconazole, Ketoconazole,
Posaconazole, Voriconazole Antiretrovirals: Atazanavir; Darunavir; Indinavir;
Lopinavir; Nelfinavir; Ombitasvir, Paritaprevir, Ritonavir and Saquinavir.
Antidepressants/ADHD: Fluvoxamine, Enoxacine. Calcium-channel blockers: Diltiazem,
Verapamil Monoclonal Antibodies: Ceritinib, Idelalisib, Lonafarnib, Tucatinib. Other
strong cytochrome P450 3A4 inhibitors: Cimetidine, Cobicistat; grapefruit juice,
Mifepristone, Nefazodone.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/07/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2028
Query!
Actual
Query!
Sample size
Target
3500
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Chris O'Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [3]
0
0
Prince of Wales Hospital - Randwick
Query!
Recruitment hospital [4]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [5]
0
0
Mackay Base Hospital - Mackay
Query!
Recruitment hospital [6]
0
0
RedCliffe Hospital - Redcliffe
Query!
Recruitment hospital [7]
0
0
Rockhampton Hospital - Rockhampton
Query!
Recruitment hospital [8]
0
0
Gold Coast University Hospital - Southport
Query!
Recruitment hospital [9]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [10]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [11]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [12]
0
0
Ballarat Base Hospital - Ballarat Central
Query!
Recruitment hospital [13]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [14]
0
0
Northern Hospital - Epping
Query!
Recruitment hospital [15]
0
0
St Vincent's Hospital, Melbourne - Fitzroy
Query!
Recruitment hospital [16]
0
0
Western Health Footscray Hospital - Footscray
Query!
Recruitment hospital [17]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [18]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [19]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [20]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [21]
0
0
Goulburn Valley Health - Shepparton
Query!
Recruitment hospital [22]
0
0
Northeast Health, Wangaratta - Wangaratta
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4740 - Mackay
Query!
Recruitment postcode(s) [5]
0
0
4020 - Redcliffe
Query!
Recruitment postcode(s) [6]
0
0
4700 - Rockhampton
Query!
Recruitment postcode(s) [7]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [8]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [9]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [10]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [11]
0
0
3350 - Ballarat Central
Query!
Recruitment postcode(s) [12]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [13]
0
0
3076 - Epping
Query!
Recruitment postcode(s) [14]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [15]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [16]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [17]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [18]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [19]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [20]
0
0
3630 - Shepparton
Query!
Recruitment postcode(s) [21]
0
0
3677 - Wangaratta
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Ohio
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Pennsylvania
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Texas
Query!
Country [4]
0
0
New Zealand
Query!
State/province [4]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Peter MacCallum Cancer Centre, Australia
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
National Health and Medical Research Council, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Australian and New Zealand College of Anaesthetists
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Victorian Comprehensive Cancer Centre
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04316013
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bernhard Riedel, MB.ChB
Query!
Address
0
0
Peter MacCallum Cancer Centre, Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Bernhard Riedel, MB.ChB
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61385597663
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04316013
Download to PDF