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

PHASE3RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-07-31

Primary completion: 2027-12-01

Study completion finish: 2028-06-01

Study type

OTHER

Phase

PHASE3

Trial ID

NCT04316013

Intervention or treatment

DRUG: Sevoflurane

DRUG: Propofol

DRUG: Lidocaine IV

Conditions

• Non Small Cell Lung Cancer
• Colonic Cancer
• Rectal Cancer

Image related to Non Small Cell Lung Cancer

Condition: Non Small Cell Lung Cancer, Colonic Cancer and more
DRUG: Sevoflurane and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Peter MacCallum Cancer Centre, Australia

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Chris O'Brien Lifehouse

Research sites nearby

Select from list below to view details:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: A Sevoflurane + intravenous lidocaine	DRUG: Sevoflurane Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
ACTIVE_COMPARATOR: B Sevoflurane	DRUG: Sevoflurane Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
ACTIVE_COMPARATOR: C Propofol TIVA + intravenous lidocaine	DRUG: Propofol Intravenous anaesthetic used for induction and maintenance of anaesthesia
ACTIVE_COMPARATOR: D Propofol TIVA	DRUG: Propofol Intravenous anaesthetic used for induction and maintenance of anaesthesia

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane	The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms.	Until 3 years from participant index surgery date
Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine	The study will collect endpoint data for each participant on time of disease progression. This will be used to compare disease free survival across arms.	Until 3 years from participant index surgery date

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane	The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.	Until 3 years from participant index surgery date
Days alive and at home with propofol-TIVA versus sevoflurane	Data will be collected at thirty days post surgery regarding date of discharge from hospital and survival status. This is then used to calculate number of days alive and at home (i.e. out of hospital) and compare across arms.	30 days post surgery
Overall survival with intravenous lidocaine versus no lidocaine	The study will collect endpoint data for each participant on survival status. This will be used to compare overall survival across arms.	Until 3 years from participant index surgery date
Days alive and at home with intravenous lidocaine versus no lidocaine	Data will be collected at thirty days post surgery regarding date of discharge from hospital and survival status. This is then used to calculate number of days alive and at home (i.e. out of hospital) and compare across arms.	30 days post surgery
Comparison of post-operative complications with propofol-TIVA versus sevoflurane	Short term postoperative morbidity assessed by the Post Operative Morbidity Scale (POMS) with Clavien-Dindo severity grading. POMS is an 18-item tool that addresses nine domains of morbidity relevant to the post-surgical patient . The severity in each POMS domain will then be graded according to the Clavien-Dindo Classification on the basis of treatment applied to correct each respective complication , and captures complications within 5 grades.	5 days post surgery or at discharge if earlier
Comparison of post-operative complications with intravenous lidocaine versus no lidocaine	Short term postoperative morbidity assessed by the Post Operative Morbidity Scale (POMS) with Clavien-Dindo severity grading. POMS is an 18-item tool that addresses nine domains of morbidity relevant to the post-surgical patient . The severity in each POMS domain will then be graded according to the Clavien-Dindo Classification on the basis of treatment applied to correct each respective complication , and captures complications within 5 grades.	5 days post surgery or at discharge if earlier
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane	Pain measured using the Brief Pain Inventory Short Form. Patient reported pain on a scale of 0 to 10 where 0 is no pain and 10 is worst pain. Pain measured using the Neuropathic Pain Questionnaire. Patient reported neuropathic pain on a scale of 0 to 100 where 0 is no pain and 100 is worst pain.	At 90 days and 12 months post surgery
Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine	Pain measured using the Brief Pain Inventory Short Form. Patient reported pain on a scale of 0 to 10 where 0 is no pain and 10 is worst pain. Pain measured using the Neuropathic Pain Questionnaire. Patient reported neuropathic pain on a scale of 0 to 100 where 0 is no pain and 100 is worst pain.	At 90 days and 12 months post surgery
Safety profile of propofol-TIVA versus sevoflurane	Toxicities measured using CTCAE V 5 .0	during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Safety Profile intravenous lidocaine versus no lidocaine	Toxicities measured using CTCAE V 5 .0	during surgery until discharge from Post Anaesthetic Care Unit (PACU) or within the first 4 hours of ICU admission
Concomitant medication use with propofol-TIVA versus sevoflurane	From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded	5 days post anaesthesia
Concomitant medications use with intravenous lidocaine versus no lidocaine	From 2 weeks prior to surgery up to Day 5 post-surgery administration of relevant medications will be recorded	5 days post anaesthesia
Health utility with propofol-TIVA versus sevoflurane	The EQ-5D-5L is a standardised instrument for use as a measure of health outcome and is applicable to a wide range of health conditions and treatments. This five item scale covers the following dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with each dimension having five levels (5L). The use of the EQ-5D-5L will enable utility valuations to be estimated for health states experienced.	At 30 days, 90 days and every 12 months post surgery up to 3 years
Health utility with intravenous lidocaine versus no lidocaine	The EQ-5D-5L is a standardised instrument for use as a measure of health outcome and is applicable to a wide range of health conditions and treatments. This five item scale covers the following dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with each dimension having five levels (5L). The use of the EQ-5D-5L will enable utility valuations to be estimated for health states experienced	At 30 days, 90 days and every 12 months post surgery up to 3 years

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References

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