Colonic CancerPhase 3NCT04316013
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial
A Phase 3 study testing Sevoflurane, Propofol and Lidocaine IV in people with Colonic Cancer and Rectal Cancer, run by Peter MacCallum Cancer Centre, Australia at 27 sites in 3 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Cancer, Rectal Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Sevoflurane, Propofol and Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 31 Jul 2020to 28 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Australia22 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Ballarat Base Hospital
Ballarat Central, Victoria, 3350
Box Hill Hospital
Box Hill, Victoria, 3128
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Northern Hospital
Epping, Victoria, 3076
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, 3065
Western Health Footscray Hospital
Footscray, Victoria, 3011
Austin Health
Heidelberg, Victoria, 3084
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
Mackay Base Hospital
Mackay, Queensland, 4740
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
The Alfred Hospital
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Prince of Wales Hospital
Randwick, New South Wales, 2031
RedCliffe Hospital
Redcliffe, Queensland, 4020
Rockhampton Hospital
Rockhampton, Queensland, 4700
Goulburn Valley Health
Shepparton, Victoria, 3630
Gold Coast University Hospital
Southport, Queensland, 4215
Northeast Health, Wangaratta
Wangaratta, Victoria, 3677
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
United States3 sites
Cleveland Clinic
Cleveland, Ohio, 44195
The University of Texas MD Anderson Cancer Centre
Houston, Texas, 77030
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
New Zealand2 sites
North Shore Hospital
Auckland, 0620
Auckland City Hospital
Auckland, 2023
About this study
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 the detailed description
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.
- Conditions
- Colonic Cancer, Rectal Cancer, Non Small Cell Lung Cancer
- Being tested
- Sevoflurane, Propofol, Lidocaine IV
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
PropofolDrug
Intravenous anaesthetic used for induction and maintenance of anaesthesia
Lidocaine IVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Sevoflurane + intravenous lidocaine Receives: Drug: Sevoflurane; Drug: Lidocaine IV |
| B | Active comparator | Sevoflurane Receives: Drug: Sevoflurane |
| C | Active comparator | Propofol TIVA + intravenous lidocaine Receives: Drug: Propofol; Drug: Lidocaine IV |
| D | Active comparator | Propofol TIVA Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Until 3 years from participant index surgery date
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 90 days and 12 months post surgery
Safety profile of propofol-TIVA versus sevoflurane
Toxicities measured using CTCAE V 5 .0
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: At 30 days, 90 days and every 12 months post surgery up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start31 Jul 2020
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Not meeting recruitment timelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Australian and New Zealand College of Anaesthetists, Victorian Comprehensive Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Bernhard Riedel, MB.ChB, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316013
- Sponsor's protocol ID
- 18/044
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2020
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Anaesthesia and Perioperative Outcomes Related to Cancer: the VAPOR-C Trial
- ClinicalTrials.gov ID
- NCT04316013
- Acronym / sponsor ID
- 18/044
- Conditions
- Colonic Cancer, Rectal Cancer, Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not meeting recruitment timelines
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Australian and New Zealand College of Anaesthetists, Victorian Comprehensive Cancer Centre
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Sevoflurane, Drug: Lidocaine IVSevoflurane + intravenous lidocaine |
| B | Active comparator | Drug: SevofluraneSevoflurane |
| C | Active comparator | Drug: Propofol, Drug: Lidocaine IVPropofol TIVA + intravenous lidocaine |
| D | Active comparator | Drug: PropofolPropofol TIVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneInhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice | Drug | A, B |
| PropofolIntravenous anaesthetic used for induction and maintenance of anaesthesia | Drug | C, D |
| Lidocaine IV1.5mg/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. | Drug | A, C |
Primary outcome
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane
Time frame: Until 3 years from participant index surgery date
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.
Comparison of disease free survival (DFS) with lidocaine compared with no lidocaine
Time frame: Until 3 years from participant index surgery date
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.
14 secondary outcomes
Comparison of overall survival (OS) with propofol-TIVA versus sevoflurane
Time frame: Until 3 years from participant index surgery date
Days alive and at home with propofol-TIVA versus sevoflurane
Time frame: 30 days post surgery
Overall survival with intravenous lidocaine versus no lidocaine
Time frame: Until 3 years from participant index surgery date
Days alive and at home with intravenous lidocaine versus no lidocaine
Time frame: 30 days post surgery
Comparison of post-operative complications with propofol-TIVA versus sevoflurane
Time frame: 5 days post surgery or at discharge if earlier
Comparison of post-operative complications with intravenous lidocaine versus no lidocaine
Time frame: 5 days post surgery or at discharge if earlier
Comparison of chronic post surgical pain with propofol-TIVA versus sevoflurane
Time frame: At 90 days and 12 months post surgery
Comparison of chronic post surgical pain with intravenous lidocaine versus no lidocaine
Time frame: At 90 days and 12 months post surgery
Safety profile of propofol-TIVA versus sevoflurane
Time frame: 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
Time frame: 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
Time frame: 5 days post anaesthesia
Concomitant medications use with intravenous lidocaine versus no lidocaine
Time frame: 5 days post anaesthesia
Health utility with propofol-TIVA versus sevoflurane
Time frame: At 30 days, 90 days and every 12 months post surgery up to 3 years
Health utility with intravenous lidocaine versus no lidocaine
Time frame: At 30 days, 90 days and every 12 months post surgery up to 3 years
Results and safety
The study was stopped early (reason given: Not meeting recruitment timelines). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Riedel, MB.ChB principal investigator
Peter MacCallum Cancer Centre, Australia
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane, Propofol and Lidocaine IV in people with Colonic Cancer and Rectal Cancer, run by Peter MacCallum Cancer Centre, Australia at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Australia, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not meeting recruitment timelines). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of disease free survival (DFS) with propofol-TIVA versus sevoflurane (time frame: Until 3 years from participant index surgery date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.