Esophageal CancerPhase 3NCT04513808
Total Intravenous Anesthesia and Recurrence Free Survival
A Phase 3 study testing Propofol-based total intravenous anesthesia and Sevoflurane intravenous anesthesia in people with Esophageal Cancer, run by The Cleveland Clinic at 1 site in China.
Trial summary
The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Propofol-based total intravenous anesthesia and Sevoflurane intravenous anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,614 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to Dec 2027
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
- Scheduled for potentially curative esophageal cancer surgery.
- Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.
Who cannot join
- Previous surgery for esophageal cancer (except diagnostic biopsies) Age <18 or >85 years old.
- ASA Physical Status ≥4.
- Any contraindication to propofol or sevoflurane.
- Other cancer not believed by the attending surgeon to be in long-term remission.
- Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanhai Chest Hospital
Shanghai
Yuwei Qui, MD, qqiuyuweixk@163.com
Yuwei
About this study
Official title: Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.
Read the detailed description
The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.
The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.
- Conditions
- Esophageal Cancer
- Being tested
- Propofol-based total intravenous anesthesia, Sevoflurane intravenous anesthesia
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol-based total intravenous anesthesiaDrug
Also called Propofol
Propofol-based total intravenous anesthesia, titrated to clinical need.
Sevoflurane intravenous anesthesiaDrug
Also called Sevoflurane
Sevoflurane intravenous anesthesia, titrated to clinical need.
| Study group | Role | What they receive |
|---|---|---|
| Propofol-based total intravenous anesthesia | Active comparator | Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary. Receives: Drug: Propofol-based total intravenous anesthesia |
| Sevoflurane intravenous anesthesia | Active comparator | Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary Receives: Drug: Sevoflurane intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Patients who did not experience cancer recurrence and/or death.
Measured: 4 years
Secondary outcomes (3)
ICU duration
Postoperative time in ICU during initial admission.
Measured: From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months
Hospital duration
Postoperative time spent in hospital during initial admission.
Measured: Up to 100 months
QoR-15
Quality of Recovery 15 score on postoperative day 2.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start15 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuwei Qiu, MD, Principal investigator, Shahai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513808
- Sponsor's protocol ID
- VICTORY
- Status last verified
- Sep 2026
- First submitted
- 12 May 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared collaboratively with appropriate approvals and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
- ClinicalTrials.gov ID
- NCT04513808
- Acronym / sponsor ID
- VICTORY
- Conditions
- Esophageal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,614 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Aug 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.
The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.
Detailed description
The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.
The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- As usual with time-to-event outcomes, enrollment will be based on the number of outcome events, not the number of patients enrolled. We anticipate that about 1614 patients will be required to generate 579 recurrences and/or deaths, but this is only a rough estimate since follow-up duration is a function of when patients are enrolled, not just their number.
| Arm | Type | Receives |
|---|---|---|
| Propofol-based total intravenous anesthesia | Active comparator | Drug: Propofol-based total intravenous anesthesiaPropofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary. |
| Sevoflurane intravenous anesthesia | Active comparator | Drug: Sevoflurane intravenous anesthesiaAnesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
- Scheduled for potentially curative esophageal cancer surgery.
- Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.
Key exclusion criteria (5 listed)
- Previous surgery for esophageal cancer (except diagnostic biopsies) Age <18 or >85 years old.
- ASA Physical Status ≥4.
- Any contraindication to propofol or sevoflurane.
- Other cancer not believed by the attending surgeon to be in long-term remission.
- Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
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 |
|---|---|---|
| Propofol-based total intravenous anesthesiaAlso: PropofolPropofol-based total intravenous anesthesia, titrated to clinical need. | Drug | Propofol-based total intravenous anesthesia |
| Sevoflurane intravenous anesthesiaAlso: SevofluraneSevoflurane intravenous anesthesia, titrated to clinical need. | Drug | Sevoflurane intravenous anesthesia |
Primary outcome
Recurrence-free survival
Time frame: 4 years
Patients who did not experience cancer recurrence and/or death.
3 secondary outcomes
ICU duration
Time frame: From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months
Hospital duration
Time frame: Up to 100 months
QoR-15
Time frame: 2 days
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 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be shared collaboratively with appropriate approvals and contracts.
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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.
Yuwei Qiu, MD principal investigator
Shahai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol-based total intravenous anesthesia and Sevoflurane intravenous anesthesia in people with Esophageal Cancer, run by The Cleveland Clinic at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
Contact Yuwei Qiu, MD (86 21 6282 1990, qiuyuweixk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 4 years). 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 8 Sep 2026.