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RecruitingLast updated: 6 December 2023

VAPOR-C: This study aims to understand the impact of anaesthesia on duration of disease free survival in patients undergoing surgery for colorectal or non-small cell lung cancerVolatile Anaesthesia and Perioperative Outcomes Related to Cancer: The VAPOR-C Trial

Clinical summary

Summary

This trial is testing the superiority of propofol (total intravenous anaesthesia -TIVA) over sevoflurane (inhalational volatile anaesthesia) and intravenous lidocaine over placebo in patients undergoing surgery for colorectal or non small cell lung cancer (NSCLC). Eligible participants will be randomly allocated to one of four treatment arms.

Conditions

This trial is treating patients with colorectal cancer or non-small cell lung cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

III

Trial Acronym

VAPOR-C

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

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

Eligibility

Inclusion

  1. Male or female patients aged 18 years or older at screening
  2. Has provided written informed consent for the trial
  3. 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.
  4. Patient has an American Society of Anaesthesiologists (ASA) score of 1 to 3
  5. Scheduled to receive elective, surgical resection with curative intent
  6. Surgery expected to last ≥2 hours and expected to require ≥2 nights hospital stay
  7. Able to comply with protocol requirements and follow-up procedures

Exclusion

  1. Confirmed or suspected allergy to propofol, sevoflurane or intravenous lidocaine
  2. Patient with significant liver disease (with elevated International Normalised Ratio (INR) or bilirubin and/or low albumin; i.e. Childs-Pugh Score >Class A;
  3. Patient at personal or familial risk of malignant hyperthermia or porphyria
  4. 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
  5. Patient has distant metastases
  6. Patient with an actual body weight less than 45kg
  7. 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.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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