Elective Surgery for Any Digestive CancerPhase 3CORTIFRENCHNCT03875690
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
A Phase 3 study testing Injection of methylprednisolone, Injection of sodium chloride and Blood samples in people with Elective Surgery for Any Digestive Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery for Any Digestive Cancer
- What is being tested?
- Injection of methylprednisolone, Injection of sodium chloride and Blood samples
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2019to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >_18 years
- Elective surgery for any digestive cancer (except purely hepatic surgery)
- Patients operated in a curative intent
- Patients who had given their written informed consent
- Patients affiliated to a National health insurance scheme
Who cannot join
- Emergency surgery
- Pregnant or breastfeeding women
- Patients with an ongoing oral treatment by steroids
- Palliative surgery
- Exclusive liver surgery
- Concomitant hyperthermic intraperitoneal chemotherapy
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- Patient with at least one contra-indication to methylprednisolone treatment :
- active infection
- progressive/symptomatic viral infection (particularly hepatitis, herpes, chickenpox, herpes zoster)
- uncontrolled psychotic state
- hypersensitivity to methylprednisolone or to one of its excipients
- ASA grade >3
- Persons subject to a measure of legal protection (guardianship, tutorship)
- Persons subject to a court order
- Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.
A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.
- Being tested
- Injection of methylprednisolone, Injection of sodium chloride, Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of methylprednisoloneDrug
Patients will receive 20mg/kg IV of methylprednisolone at the time of anaesthetic induction. Methylprednisolone will be infused in a ready-to-use 50 mL bag of sodium chloride 0.9% during 30 minutes at anaesthesic induction.
Injection of sodium chlorideDrug
patients in the placebo group will receive 50 mL of sodium chloride 0.9% in a ready-to-use bag during 30 minutes at anaesthesic induction.
Blood samplesBiological
electrolyte panel and glycemia performed within the first 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Injection of methylprednisolone; Biological: Blood samples |
| Control group | Placebo comparator | Not described Receives: Drug: Injection of sodium chloride; Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of patients with postoperative major complications occurring within 30 days after surgery
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start2 Jul 2019
- Primary completion29 Feb 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective Surgery for Any Digestive CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875690
- Sponsor's protocol ID
- ORTEGA PHRCK 2017
- Acronym
- CORTIFRENCH
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ortega-Deballon P, Bourredjem A, Regimbeau JM, Zerbib P, Facy O, Piessen G, Orry D, Doussot A, Deguelte-Lardiere S, Porta-Bonete G, Beyer-Berjot L, Schwarz L, Buisset C, Mauvais F, Marchese U, Ayav A, Souche FR, Borraccino B, Venara A, Gaujoux S, Passot G, Trelles N, Herrero A, Messager M, Tresallet C, Valverde A, Fournel I, Benoist S; CORTIFRENCH Investigators. Preoperative High-Dose Corticosteroids in Digestive Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Aug 19:e263557. doi: 10.1001/jamasurg.2026.3557. Online ahead of print.
PubMed 42616512Magnin J, Fournel I, Doussot A, Regimbeau JM, Zerbib P, Piessen G, Beyer-Berjot L, Deguelte S, Lakkis Z, Schwarz L, Orry D, Ayav A, Muscari F, Mauvais F, Passot G, Trelles N, Venara A, Benoist S, Messager M, Fuks D, Borraccino B, Tresallet C, Valverde A, Souche FR, Herrero A, Gaujoux S, Lefevre J, Bourredjem A, Cransac A, Ortega-Deballon P. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH). BMC Cancer. 2022 Aug 23;22(1):913. doi: 10.1186/s12885-022-09998-z.
PubMed 35999521
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03875690
- Acronym / sponsor ID
- CORTIFRENCH / ORTEGA PHRCK 2017
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Mar 2019 (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.
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.
A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Injection of methylprednisolone, Biological: Blood samples |
| Control group | Placebo comparator | Drug: Injection of sodium chloride, Biological: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >_18 years
- Elective surgery for any digestive cancer (except purely hepatic surgery)
- Patients operated in a curative intent
- Patients who had given their written informed consent
- Patients affiliated to a National health insurance scheme
Key exclusion criteria (15 listed)
- Emergency surgery
- Pregnant or breastfeeding women
- Patients with an ongoing oral treatment by steroids
- Palliative surgery
- Exclusive liver 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 |
|---|---|---|
| Injection of methylprednisolonePatients will receive 20mg/kg IV of methylprednisolone at the time of anaesthetic induction. Methylprednisolone will be infused in a ready-to-use 50 mL bag of sodium chloride 0.9% during 30 minutes at anaesthesic induction. | Drug | Experimental group |
| Injection of sodium chloridepatients in the placebo group will receive 50 mL of sodium chloride 0.9% in a ready-to-use bag during 30 minutes at anaesthesic induction. | Drug | Control group |
| Blood sampleselectrolyte panel and glycemia performed within the first 24 hours after surgery. | Biological | Control group, Experimental group |
Primary outcome
frequency of patients with postoperative major complications occurring within 30 days after surgery
Time frame: Through study completion, an average of 5 years
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 20 Jan 2026.
- Derived from this study: PubMed 42616512Ortega-Deballon P, Bourredjem A, Regimbeau JM, Zerbib P, Facy O, Piessen G, Orry D, Doussot A, Deguelte-Lardiere S, Porta-Bonete G, Beyer-Berjot L, Schwarz L, Buisset C, Mauvais F, Marchese U, Ayav A, Souche FR, Borraccino B, Venara A, Gaujoux S, Passot G, Trelles N, Herrero A, Messager M, Tresallet C, Valverde A, Fournel I, Benoist S; CORTIFRENCH Investigators. Preoperative High-Dose Corticosteroids in Digestive Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Aug 19:e263557. doi: 10.1001/jamasurg.2026.3557. Online ahead of print.
- Derived from this study: PubMed 35999521Magnin J, Fournel I, Doussot A, Regimbeau JM, Zerbib P, Piessen G, Beyer-Berjot L, Deguelte S, Lakkis Z, Schwarz L, Orry D, Ayav A, Muscari F, Mauvais F, Passot G, Trelles N, Venara A, Benoist S, Messager M, Fuks D, Borraccino B, Tresallet C, Valverde A, Souche FR, Herrero A, Gaujoux S, Lefevre J, Bourredjem A, Cransac A, Ortega-Deballon P. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH). BMC Cancer. 2022 Aug 23;22(1):913. doi: 10.1186/s12885-022-09998-z.
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.
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 Injection of methylprednisolone, Injection of sodium chloride and Blood samples in people with Elective Surgery for Any Digestive Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 15 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 20 Jan 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 France. 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. Some participants in this study may receive a placebo. 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?
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?
frequency of patients with postoperative major complications occurring within 30 days after surgery (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875690, which also lists 2 linked publications.
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 20 Jan 2026.