Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial
Megadott ok: Not meeting recruitment timelines
Key facts
- Where
- Adelaide, Ballarat Central, Box Hill, Camperdown, Epping, Fitzroy, Footscray, Heidelberg, Herston, Hobart, Mackay, Melbourne, Parkville, Randwick, Redcliffe, Rockhampton, Shepparton, Southport, Wangaratta és Woolloongabba, AusztráliaSee the 22 sites
- Phase
- 3. fázis
Where in Ausztrália
- Royal Adelaide HospitalAdelaide, AusztráliaNo longer taking part
- Ballarat Base HospitalBallarat Central, AusztráliaNo longer taking part
- Box Hill HospitalBox Hill, AusztráliaNo longer taking part
- Chris O'Brien LifehouseCamperdown, AusztráliaNo longer taking part
- Royal Prince Alfred HospitalCamperdown, AusztráliaNo longer taking part
- Northern HospitalEpping, AusztráliaNo longer taking part
- St Vincent's Hospital MelbourneFitzroy, AusztráliaNo longer taking part
- Western Health/Footscray HospitalFootscray, AusztráliaNo longer taking part
- Austin HealthHeidelberg, AusztráliaNo longer taking part
- Royal Brisbane and Women's HospitalHerston, AusztráliaNo longer taking part
- Royal Hobart HospitalHobart, AusztráliaNo longer taking part
- Mackay Base HospitalMackay, AusztráliaNo longer taking part
- Peter MacCallum Cancer CentreMelbourne, AusztráliaNo longer taking part
- The Alfred HospitalMelbourne, AusztráliaNo longer taking part
- The Royal Melbourne HospitalParkville, AusztráliaNo longer taking part
- Prince of Wales HospitalRandwick, AusztráliaNo longer taking part
- Redcliffe HospitalRedcliffe, AusztráliaNo longer taking part
- Rockhampton HospitalRockhampton, AusztráliaNo longer taking part
- Goulburn Valley HealthShepparton, AusztráliaNo longer taking part
- Gold Coast University HospitalSouthport, AusztráliaNo longer taking part
- Northeast Health WangarattaWangaratta, AusztráliaNo longer taking part
- Princess Alexandra HospitalWoolloongabba, AusztráliaNo longer taking part
Trial details
- Who runs it
- Peter MacCallum Cancer Centre, Australia
- Trial code
- NCT04316013
- Record updated
- 2025. március 14.
- Original description
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.Read full original descriptionShow less
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.
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 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 with significant liver disease (with elevated International Normalised Ratio (INR) or bilirubin and/or low albumin; i.e. Childs-Pugh Score >Class A; 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; Patient has distant metastases; Patient with an actual body weight less than 45kg.