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

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

VAPOR-C is a randomised study of the impact of IV versus inhaled anaesthesia (propofol versus sevoflurane) and lidocaine versus placebo on duration of disease free survival inpatients with either colorectal or non small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Collaborators: National Health & Medical Research Council of Australia (NH&MRC); The Australian and New Zealand College of Anaesthetists (ANZCA); Victorian Comprehensive Cancer Centre
• Treatments: Anesthetics; Lidocaine; Propofol; Sevoflurane

Criteria

Inclusion Criteria:

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 Criteria:

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

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. Patient has an albumin level < 25 g/L

8. Patient has overt clinical heart failure

9. Patients taking the following drugs within 72 hours prior to surgery:

Antibiotics: Clarithromycin, Telithromycin, Azithromycin, Erythromycin, Ciprofloxacin, Norfloxacin, Levofloxacin, Sparfloxacin, Isoniazid, Roxithromycin, Chloramphenicol Antidepressants: Fluvoxamine Calcium-channel blockers: Diltiazem, Nifedipine, Verapamil