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Not meeting recruitment timelines
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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| Australian and New Zealand College of Anaesthetists | OTHER |
| Victorian Comprehensive Cancer Centre | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Sevoflurane + intravenous lidocaine |
|
| B | Active Comparator | Sevoflurane |
|
| C | Active Comparator | Propofol TIVA + intravenous lidocaine |
|
| D | Active Comparator | Propofol TIVA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of return to intended oncological treatment (RIOT) with propofol-TIVA versus sevoflurane | Data will be collected post surgery regarding post treatment adjuvant therapy given according to plan. A comparison will be made between number of participants receiving post surgery oncological treatment as planned and the number of patients deviating from the plan in each arm of the study. | At 90 days and 12 months post surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard Riedel, MB.ChB | Peter MacCallum Cancer Centre, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| University of Pittsburgh Medical Center |
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This is an event-driven, international multicentre, randomised controlled trial with a 2x2 factorial design. Patients with stage I-III colorectal cancer or stage I-IIIa NSCLC are eligible and will be randomised in the ratio of 1:1:1:1 using permuted block randomisation with stratification by cancer type (Colon, Rectal or NSCLC), and by site to receive either 1) sevoflurane maintenance anaesthesia and lidocaine infusion or 2) sevoflurane maintenance anaesthesia; or 3), propofol maintenance anaesthesia and lidocaine infusion or 4), propofol maintenance anaesthesia .
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The propofol-TIVA/sevoflurane element of each arm will have a single blind (patient blinded), as the administering anesthesiologist cannot be blinded to allocation. The lidocaine infusion or no lidocaine infusion element of each ARM will be blinded to the patient . The anaesthetic team and research team caring for the patient will not be blinded to the lidocaine infusion/no lidocaine infusion element of the randomisation ARM
| Propofol | Drug | Intravenous anaesthetic used for induction and maintenance of anaesthesia |
|
| Lidocaine IV | Drug | 1.5mg/kg loading dose over 20 minutes, followed by an infusion of 2mg/kg/hr up to 4 hours and 1.5mg/kg/hour thereafter. Bolus and maintenance dosages of lidocaine will be per actual body weight and capped at a maximum of 100 kg. |
|
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 |
| Comparison of return to intended oncological treatment (RIOT) with intravenous lidocaine versus no lidocaine | Data will be collected post surgery regarding post treatment adjuvant therapy given according to plan. A comparison will be made between number of participants receiving post surgery oncological treatment as planned and the number of patients deviating from the plan in each arm of the study. | At 90 days and 12 months post surgery |
| Correlative blood studies | Inflammatory markers - Neutrophil to lymphocyte ratio (NLR), Platelet to lymphocyte ratio (PLR), C-reactive protein (CRP) Circulating tumour deoxyribonucleic acid (ctDNA), DNA/RNA, Circulating tumour cells (CTCs), immune profile using flow cytometry and plasma for cytokines These are exploratory transnational research outcomes levels of these biomarkers will be measured over the course of the study and analysed for correlation the study outcomes. | Preop, Day 1, 3 and 5 (if still an inpatient) and at recurrence |
| Correlative breath biopsy studies | To characterise the effect of anaesthetic agents on perioperative inflammatory changes will measure Targeted Volatile Organic Compounds of the eicosanoid pathway by sampling patients breath (breath biopsy) to monitor inflammatory changes within the pulmonary compartment. | Preop, Day 1, 3 and 5 (if still an inpatient) and at recurrence |
| MINS Substudy | At sites who agree to participate: Blood Specimens and 12-Lead ECG - 12 Lead ECGS will be done and blood specimens collected to measure Troponin levels at baseline, Day 1 and Day 2 post op. Assessment of the predefined diagnostic criteria for MINS and perioperative myocardial infarction on Day 5 or Discharge if earlier Assessment of predefined diagnostic criteria for MINS and myocardial infarction at 30 days post op. | Day 0 to day 30 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| The University of Texas MD Anderson Cancer Centre | Houston | Texas | 77030 | United States |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mackay Base Hospital | Mackay | Queensland | 4740 | Australia |
| RedCliffe Hospital | Redcliffe | Queensland | 4020 | Australia |
| Rockhampton Hospital | Rockhampton | Queensland | 4700 | Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Ballarat Base Hospital | Ballarat Central | Victoria | 3350 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Northern Hospital | Epping | Victoria | 3076 | Australia |
| St Vincent's Hospital, Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Western Health Footscray Hospital | Footscray | Victoria | 3011 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Goulburn Valley Health | Shepparton | Victoria | 3630 | Australia |
| Northeast Health, Wangaratta | Wangaratta | Victoria | 3677 | Australia |
| North Shore Hospital | Auckland | 0620 | New Zealand |
| Auckland City Hospital | Auckland | 2023 | New Zealand |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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