Overview
Sponsor-declared trial summary
Patients with gastric cancer
TO investigate if preoperative iron infusion decreases the risk of transfusions and complications in after operation for gastric cancer.
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Helsinki University Hospital Research Fund · Helsinki University Research Fund
External identifiers
- EU CT number
- 2024-519738-21-01
- EudraCT number
- 2019-001005-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
TO investigate if preoperative iron infusion decreases the risk of transfusions and complications in after operation for gastric cancer.
Conditions and MedDRA coding
Patients with gastric cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519738-21-00 | Preoperative intravenous iron therapy in patients with gastric cancer | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients with gastric cancer
Exclusion criteria 1
- Patients under 18 years old Patients not in full understanding Hemoglobin levels > 155 g/l for women and >167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively. Transferrin saturation level >50% Emergency gastrectomy Palliative gastrectomy Acute bacterial infection Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products Clinical evidence of iron overload or disturbances in the utilisation of iron Patients <35 kg Dialysis therapy for chronic renal failure Hemochromatosis Polycytemia vera Pregnancy Patients in need of direct blood transfusion
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of patients receiving transfusions
Secondary endpoints 1
- Postoperative Hb level, complications and quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ferinject 50 mg Fe/ml injektio-/infuusioneste, dispersio.
PRD469657 · Product
- Active substance
- Ferric Carboxymaltose
- Pharmaceutical form
- DISPERSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- B03AC — IRON TRIVALENT, PARENTERAL PREPARATIONS
- Marketing authorisation
- 22144
- MA holder
- VIFOR FRANCE
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid 9 mg/ml “Fresenius Kabi“
PRD2128221 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 920244
- MA holder
- FRESENIUS KABI AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Arto Kokkola
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Arto Kokkola
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 202 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | 1 |
| Recruitment arrangements (for publication) | Arrangements | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan suostumus | 1 |
| Subject information and informed consent form (for publication) | Tutkittavan tiedote | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Valmisteyhteenveto | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Finland | Acceptable 2024-12-16
|
2024-12-16 |