Clinical trial NCT03875690: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Official title: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Elective Surgery for Any Digestive Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Emergency surgery
* Pregnant or breastfeeding women
* Patients with an ongoing oral treatment by steroids
* Palliative surgery
* Exclusive liver surgery
* Concomitant hyperthermic intraperitoneal chemotherapy
* 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

Primary outcomes:
measure: frequency of patients with postoperative major complications occurring within 30 days after surgery
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu de Dijon
Study officials:
References:
citation: Magnin 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.