Lung Cancer Clinical Trial

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

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.

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Full 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.

This trial is designed to test for superiority in disease free survival (DFS) of propofol (total intravenous anaesthesia -TIVA) over sevoflurane (inhalational volatile anaesthesia) and intravenous lidocaine over no lidocaine in patients undergoing surgery for colorectal or non small cell lung cancer (NSCLC). The combination of two cancer types will help address the need to demonstrate the effects of anaesthetic technique across cancers to inform generalisable anaesthesia guidelines. Both NSCLC and colorectal cancer are important for this study due to high incidence rate, many longer-term survivors, and importantly the high risk of local or distant recurrence despite complete surgical resection. In addition, the study will collect additional data in a nested cohort related to the exploratory objectives.

The study aims to recruit 3,500 patients in Australia, New Zealand, Canada, United States and Europe.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

3500

Study ID:

NCT04316013

Recruitment Status:

Recruiting

Sponsor:

Peter MacCallum Cancer Centre, Australia

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There are 26 Locations for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Kamal Maheshwari, MD
Contact
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States More Info
Aman Mahajan, MD, PhD, MBA
Contact
The University of Texas MD Anderson Cancer Centre
Houston Texas, 77030, United States More Info
Juan Cata, MD
Contact
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia More Info
Paul Drakeford
Contact
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia More Info
Neil Pillinger
Contact
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia More Info
Michael Bennett
Contact
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia More Info
Victoria Eley
Contact
Mackay Base Hospital
Mackay Queensland, 4740, Australia More Info
Suresh Singaravelu
Contact
RedCliffe Hospital
Redcliffe Queensland, 4020, Australia More Info
Mattys Campher
Contact
Rockhampton Hospital
Rockhampton Queensland, 4700, Australia More Info
Michael Tripet
Contact
Gold Coast University Hospital
Southport Queensland, 4215, Australia More Info
Rachel Bourke
Contact
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia More Info
Pal Sivalingam
Contact
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Thomas Painter
Contact
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia More Info
Michael Challis
Contact
Ballarat Base Hospital
Ballarat Central Victoria, 3350, Australia More Info
Gregory Henderson
Contact
Box Hill Hospital
Box Hill Victoria, 3128, Australia More Info
Tarin Ward
Contact
Northern Hospital
Epping Victoria, 3076, Australia More Info
Darren Lowen
Contact
St Vincent's Hospital, Melbourne
Fitzroy Victoria, 3065, Australia More Info
Desmond McGlade
Contact
Western Health Footscray Hospital
Footscray Victoria, 3011, Australia More Info
Nicole Sheridan
Contact
Austin Health
Heidelberg Victoria, 3084, Australia More Info
Laurence Weinberg
Contact
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia More Info
Bernhard Riedel
Contact
The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Paul Myles
Contact
The Royal Melbourne Hospital
Parkville Victoria, 3050, Australia More Info
Kate Leslie
Contact
Goulburn Valley Health
Shepparton Victoria, 3630, Australia More Info
Nigel Dunk
Contact
Northeast Health, Wangaratta
Wangaratta Victoria, 3677, Australia More Info
Anthony Baird
Contact
North Shore Hospital
Auckland , 0620, New Zealand More Info
Manson Ku
Contact
Auckland City Hospital
Auckland , 2023, New Zealand More Info
Anna Waylen
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

3500

Study ID:

NCT04316013

Recruitment Status:

Recruiting

Sponsor:


Peter MacCallum Cancer Centre, Australia

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