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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04074460




Registration number
NCT04074460
Ethics application status
Date submitted
15/08/2019
Date registered
30/08/2019
Date last updated
9/06/2022

Titles & IDs
Public title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study
Scientific title
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Secondary ID [1] 0 0
16/144
Universal Trial Number (UTN)
Trial acronym
VAPOR-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer, Breast 0 0
Cancer Colorectal 0 0
Cancer Prostate 0 0
Cancer, Lung 0 0
Cancer Melanoma Skin 0 0
Cancer, Other 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Propofol
Treatment: Drugs - isoflurane, sevoflurane or desflurane

Active Comparator: Propofol (TIVA) - Propofol-based total intravenous anaesthesia

Active Comparator: Volatile - Volatile-based (isoflurane, sevoflurane or desflurane) general anaesthesia


Treatment: Drugs: Propofol
General Anaesthesia

Treatment: Drugs: isoflurane, sevoflurane or desflurane
General Anaesthesia
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To measure the ability to recruit eligible patients into the study.
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.
Timepoint [2] 0 0
18 months
Secondary outcome [1] 0 0
To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap).
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
To test the efficiency of the centralized patient enrolment and computer randomization system.
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
- Male or female

- Age 18-80 years

- Elective surgery

- Major cancer surgery expecting to last two or more hours, for:

- Breast (mastectomy or segmentectomy plus sentinel node dissection)

- Colorectal

- Lung

- Prostate

- Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap
construction

- Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Palliative surgery for end-stage disease with no curative intent

- Emergency surgery

- Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4

- Age <18 or >80 years old

- Refusal or inability to provide valid informed consent

- Risk of severe postoperative nausea and vomiting (PONV risk score >3)

- Previous allergy or contraindication to either anaesthetic medication

- Indication for gas induction of anaesthesia

- Currently enrolled in another clinical trial unless agreed by the coordinating
principal investigator and site principal investigator that co-enrolment can occur.

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

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

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
M.D. Anderson Cancer Center
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Alfred
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based
anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of
anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing
elective major cancer surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04074460
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04074460