Status:
TERMINATED
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Australian and New Zealand College of Anaesthetists
Conditions:
Colonic Cancer
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
VAPOR-C is a pragmatic, event-driven, randomised controlled trial, with a single blind 2x2 factorial design for sevoflurane/propofol and for intravenous lidocaine infusion / no lidocaine infusion. Th...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years or older at screening
- Has provided written informed consent for the trial
- 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.
- Patient has an American Society of Anaesthesiologists (ASA) score of 1 to 3
- Scheduled to receive elective, surgical resection with curative intent
- Surgery expected to last ≥2 hours and expected to require ≥2 nights hospital stay
- Able to comply with protocol requirements and follow-up procedures
Exclusion
- Confirmed or suspected allergy to propofol, sevoflurane or intravenous lidocaine
- 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
- 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
- Patient has distant metastases
- Patient with an actual body weight less than 45kg
- 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.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04316013
Start Date
July 31 2020
End Date
February 28 2025
Last Update
March 14 2025
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
3
The University of Texas MD Anderson Cancer Centre
Houston, Texas, United States, 77030
4
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050