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Gastric CancerPhase 4IRONSTOMACHNCT04168346

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

A Phase 4 study testing Ferric carboxymaltose in people with Gastric Cancer and Anemia, run by Helsinki University Central Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Anemia, Surgery
What is being tested?
Ferric carboxymaltose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
No sites listed yet
Study dates
Nov 2019to Nov 2026
Phase
Phase 4
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

  • Patients with gastric cancer who will undergo a gastrectomy

Who cannot join

  • 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
Show all 15Show fewer
  • 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
  • Polycythemia vera
  • Pregnancy
  • Patients in need of direct blood transfusion ( Criteria for this are hemoglobin < 80 g/l or < 90 g/l if the patient is symptomatic or has a history of heart disease)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Arto Kokkola, MD contact

+358-9-4711

arto.kokkola@hus.fi

About this study

The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.

Being tested
Ferric carboxymaltose, Placebos
Medical subject headings
Stomach Neoplasms, Anemia, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric carboxymaltoseDrug

    Ferric carboxymaltose iv infusion

  • PlacebosDrug

    NaCl 0.9% infusion

Study groups in NCT04168346
Study groupRoleWhat they receive
InterventionExperimentalIV-iron substitution: The intravenous iron formulation used in the study is ferric carboxymaltose and it will be administered two to four weeks before the surgery, aiming at four weeks. The dose of intravenous iron will be calculated according to the weight and haemoglobin level of the patients, however so that all the patients receive minimum 1000mg iv iron and the maximum dose is 20 mg/kg per day.
Receives: Drug: Ferric carboxymaltose
PlaceboPlacebo comparatorPlacebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The need for blood transfusion

    Number of patients needing transfusions

    Measured: Within 30 days from the day of the operation

Secondary outcomes (16)

  1. Postoperative complications

    Postoperative complications measured using Comprehensive complication index

    Measured: Within 30 days from operation

  2. Patients' quality of life (RAND)

    RAND questionnaires

    Measured: One and six months after the surgery

  3. Patients' quality of life (15D)

    15D questionnaires

    Measured: One and six months after the surgery

  4. Patients' quality of life (EQ-5D)

    EQ-5D questionnaires

    Measured: One and six months after the surgery

  5. Patients' quality of life (FRAIL)

    FRAIL questionnaires

    Measured: One and six months after the surgery

  6. Patients' quality of life (PRISMA-7)

    PRISMA-7 questionnaires

    Measured: One and six months after the surgery

  7. Patients' quality of life (GSRS)

    GSRS questionnaires

    Measured: One and six months after the surgery

  8. Patients' quality of life (IDQ)

    IDQ questionnaires

    Measured: One and six months after the surgery

  9. Patients' haemoglobin and iron parameter levels

    Patients' haemoglobin and iron parameter levels

    Measured: At the time of hospital discharge (estimated on average 10 days after surgery)

  10. Patients' haemoglobin and iron parameter levels

    Patients' haemoglobin and iron parameter levels

    Measured: One month after the surgery

  11. Patients' haemoglobin and iron parameter levels

    Patients' haemoglobin and iron parameter levels

    Measured: Three months after the surgery

  12. Re-admission

    Patient re-admission rates

    Measured: 30 days after discharge from hospital

  13. 90-day mortality

    90-day mortality

    Measured: Within 90 days from operation

  14. Overall survival

    Overall survival

    Measured: 1, 3 and 5 years from operation

  15. Length of hospital stay

    Length of hospital stay

    Measured: Within hospital stay, on average 7 - 14 days

  16. Use of IV iron after operation

    Number of doses and median dose of IV iron

    Measured: Within 3 months from operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study startNov 2019 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168346
Sponsor's protocol ID
HUS/333/2019
Acronym
IRONSTOMACH
Status last verified
Nov 2019
First submitted
12 Nov 2019
Last updated
19 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferric carboxymaltose in people with Gastric Cancer and Anemia, run by Helsinki University Central Hospital.

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 1 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: opening soon, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Arto Kokkola, MD (+358-9-4711, arto.kokkola@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The need for blood transfusion (time frame: Within 30 days from the day of the operation). 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 NCT04168346.

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 19 Nov 2019.

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