Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial

Stopped early · Phase 3

Conditions studied: Colonic Cancer, Rectal Cancer, Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04316013

Run by

Peter MacCallum Cancer Centre, Australia

People needed

254

Starts

2020-07-31

Expected to finish

2025-02-28

Last updated by the study team

2025-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Centre — Houston, Texas, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Mackay Base Hospital — Mackay, Queensland, Australia
• RedCliffe Hospital — Redcliffe, Queensland, Australia
• Rockhampton Hospital — Rockhampton, Queensland, Australia
• Gold Coast University Hospital — Southport, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Ballarat Base Hospital — Ballarat Central, Victoria, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• Northern Hospital — Epping, Victoria, Australia
• St Vincent's Hospital, Melbourne — Fitzroy, Victoria, Australia
• Western Health Footscray Hospital — Footscray, Victoria, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Goulburn Valley Health — Shepparton, Victoria, Australia
• Northeast Health, Wangaratta — Wangaratta, Victoria, Australia

Full record on ClinicalTrials.gov

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