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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04316013




Registration number
NCT04316013
Ethics application status
Date submitted
22/01/2020
Date registered
20/03/2020

Titles & IDs
Public title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial
Scientific title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial
Secondary ID [1] 0 0
18/044
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Cancer 0 0
Rectal Cancer 0 0
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane
Timepoint [1] 0 0
Until 3 years from participant index surgery date
Primary outcome [2] 0 0
Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine
Timepoint [2] 0 0
Until 3 years from participant index surgery date
Secondary outcome [1] 0 0
Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane
Timepoint [1] 0 0
Until 3 years from participant index surgery date
Secondary outcome [2] 0 0
Days alive and at home with propofol-TIVA versus sevoflurane
Timepoint [2] 0 0
30 days post surgery
Secondary outcome [3] 0 0
Overall survival with intravenous lidocaine versus no lidocaine
Timepoint [3] 0 0
Until 3 years from participant index surgery date
Secondary outcome [4] 0 0
Days alive and at home with intravenous lidocaine versus no lidocaine
Timepoint [4] 0 0
30 days post surgery
Secondary outcome [5] 0 0
Comparison of post-operative complications with propofol-TIVA versus sevoflurane
Timepoint [5] 0 0
5 days post surgery or at discharge if earlier
Secondary outcome [6] 0 0
Comparison of post-operative complications with intravenous lidocaine versus no lidocaine
Timepoint [6] 0 0
5 days post surgery or at discharge if earlier
Secondary outcome [7] 0 0
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Timepoint [7] 0 0
At 90 days and 12 months post surgery
Secondary outcome [8] 0 0
Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine
Timepoint [8] 0 0
At 90 days and 12 months post surgery
Secondary outcome [9] 0 0
Safety profile of propofol-TIVA versus sevoflurane
Timepoint [9] 0 0
during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Secondary outcome [10] 0 0
Safety Profile intravenous lidocaine versus no lidocaine
Timepoint [10] 0 0
during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Secondary outcome [11] 0 0
Concomitant medication use with propofol-TIVA versus sevoflurane
Timepoint [11] 0 0
5 days post anaesthesia
Secondary outcome [12] 0 0
Concomitant medications use with intravenous lidocaine versus no lidocaine
Timepoint [12] 0 0
5 days post anaesthesia
Secondary outcome [13] 0 0
Health utility with propofol-TIVA versus sevoflurane
Timepoint [13] 0 0
At 30 days, 90 days and every 12 months post surgery up to 3 years
Secondary outcome [14] 0 0
Health utility with intravenous lidocaine versus no lidocaine
Timepoint [14] 0 0
At 30 days, 90 days and every 12 months post surgery up to 3 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [6] 0 0
RedCliffe Hospital - Redcliffe
Recruitment hospital [7] 0 0
Rockhampton Hospital - Rockhampton
Recruitment hospital [8] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 0 0
Ballarat Base Hospital - Ballarat Central
Recruitment hospital [13] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [14] 0 0
Northern Hospital - Epping
Recruitment hospital [15] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [16] 0 0
Western Health Footscray Hospital - Footscray
Recruitment hospital [17] 0 0
Austin Health - Heidelberg
Recruitment hospital [18] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [19] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [20] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [21] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [22] 0 0
Northeast Health, Wangaratta - Wangaratta
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4740 - Mackay
Recruitment postcode(s) [5] 0 0
4020 - Redcliffe
Recruitment postcode(s) [6] 0 0
4700 - Rockhampton
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3076 - Epping
Recruitment postcode(s) [14] 0 0
3065 - Fitzroy
Recruitment postcode(s) [15] 0 0
3011 - Footscray
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3000 - Melbourne
Recruitment postcode(s) [18] 0 0
3004 - Melbourne
Recruitment postcode(s) [19] 0 0
3050 - Parkville
Recruitment postcode(s) [20] 0 0
3630 - Shepparton
Recruitment postcode(s) [21] 0 0
3677 - Wangaratta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand College of Anaesthetists
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Victorian Comprehensive Cancer Centre
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bernhard Riedel, MB.ChB
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bernhard Riedel, MB.ChB
Address 0 0
Country 0 0
Phone 0 0
+61385597663
Fax 0 0
Email 0 0
bernhard.riedel@petermac.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04316013