Cancer of ColonNCT04259398
Anesthesia and Cancer Study: Colon Cancer
A study testing Propofol and Sevoflurane in people with Cancer of Colon and Anesthesia, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cancer of Colon, Anesthesia
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 797 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Feb 2020to 3 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults undergoing surgery to remove colon cancer
Who cannot join
- pregnancy
- colon cancer with invasion to perineum
- palliative surgery
- history of diagnosis or surgery for other cancer
- emergent surgery
- ASA PS classification 4 and 5
- refusion to participate in the study
- allergy to anesthetics
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
Seoul National University Hospital
Seoul, 110-744
About this study
Official title: The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study
This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.
Read the detailed description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.
- Conditions
- Cancer of Colon, Anesthesia
- Being tested
- Propofol, Sevoflurane
- Keywords
- anesthesia, propofol, cancer, inhalational anesthetics
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
SevofluraneDrug
sevoflurane is administered for induction and maintenance of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Experimental | propofol infusion targeting bispectral index 40-60 Receives: Drug: Propofol |
| inhalation (Sevoflurane) | Active comparator | sevoflurane targeting bispectral index 40-60 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
five year survival
survival rate regardless of recurrence
Measured: five years survival
Secondary outcomes (5)
five year recurrence free survival
survival rate without recurrence
Measured: five years after surgery
1 year recurrence free survival
survival rate without recurrence
Measured: 1 year after surgery
3 year recurrence free survival
survival rate without recurrence
Measured: 3 years after surgery
1 year survival
survival regardless of recurrence
Measured: 1 year after surgery
3 year survival
survival regardless of recurrence
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start18 Feb 2020
- Primary completion3 May 2028 (estimated)
- Study completion3 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Society of Anesthesiologists, Seoul National University Bundang Hospital, Chung-Ang University Hospital, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259398
- Sponsor's protocol ID
- Ane-Can colon (1912-133-109)
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04259398
- Acronym / sponsor ID
- Ane-Can colon (1912-133-109)
- Conditions
- Cancer of Colon, Anesthesia
- Keywords
- anesthesia, propofol, cancer, inhalational anesthetics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 797 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Society of Anesthesiologists, Seoul National University Bundang Hospital, Chung-Ang University Hospital, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 3 May 2028 (estimated)
- Study completion
- 3 May 2028 (estimated)
- First posted
- 6 Feb 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.
This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.
Detailed description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA | Experimental | Drug: Propofolpropofol infusion targeting bispectral index 40-60 |
| inhalation (Sevoflurane) | Active comparator | Drug: Sevofluranesevoflurane targeting bispectral index 40-60 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults undergoing surgery to remove colon cancer
Key exclusion criteria (8 listed)
- pregnancy
- colon cancer with invasion to perineum
- palliative surgery
- history of diagnosis or surgery for other cancer
- emergent surgery
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 |
|---|---|---|
| Propofolpropofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia | Drug | TIVA |
| Sevofluranesevoflurane is administered for induction and maintenance of anesthesia | Drug | inhalation (Sevoflurane) |
Primary outcome
five year survival
Time frame: five years survival
survival rate regardless of recurrence
5 secondary outcomes
five year recurrence free survival
Time frame: five years after surgery
1 year recurrence free survival
Time frame: 1 year after surgery
3 year recurrence free survival
Time frame: 3 years after surgery
1 year survival
Time frame: 1 year after surgery
3 year survival
Time frame: 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Cancer of Colon and Anesthesia, run by Seoul National University Hospital at 2 sites in South Korea.
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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
five year survival (time frame: five years survival). 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 22 Nov 2023.