Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune system processes [G12]

Trial duration

2 Jul 2019 → ongoing

Decision date (initial)

2024-07-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513728-40-00

EudraCT number

2018-004852-39

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

to assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications after elective curative-intent surgery for digestive cancer

Secondary objectives 2

1. Efficacy: to assess the effect of a preoperative flash dose of corticosteroids versus placebo on: - Overall survival at 3 years - Disease-free survival at 3 years - Postoperative infections at D30 - Intraabdominal infections at D30 - Hospital stay duration
2. Safety: to assess the safety of a preoperative flash dose of corticosteroids

Conditions and MedDRA coding

scheduled surgery for digestive cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age > or = 18 years
2. Elective surgery for any digestive cancer (except purely hepatic surgery)
3. Patients operated in a curative intent
4. Patients who had given their written informed consent
5. Patients affiliated to a National health insurance scheme

Exclusion criteria 13

1. Emergency surgery
2. Pregnant or breastfeeding women
3. Patients with an ongoing oral treatment by steroids
4. Palliative surgery
5. Exclusive liver surgery
6. concomitant hyperthermic intraperitoneal chemotherapy
7. 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
8. ASA grade >3
9. Persons subject to a measure of legal protection (guardianship, tutorship)
10. Persons subject to a court order
11. Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
12. Secondary exclusion criteria : live vaccine or live attenuated vaccine administered within 1 month preceding surgery
13. Secondary exclusion criteria : cancelled surgery without deferral

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. frequency of patients with postoperative major complications occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2

Secondary endpoints 6

1. Efficacy: - Overall survival at 3 years (time from surgery to death from any cause)
2. Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first)
3. Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions
4. Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition)
5. Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30
6. Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by blood samples within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

2 Boulevard Mal De Lattre De Tassigny

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets recherche

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de projets recherche

Locations

1 EU/EEA country · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications