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Pancreatic CancerPhase 2FCMNCT02628860

Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

A Phase 2 study testing Ferinject (Ferric Carboxymaltose) in people with Pancreatic Cancer and Anemia, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pancreatic Cancer, Anemia
What is being tested?
Ferinject (Ferric Carboxymaltose)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to 27 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥19 years old
  • anticipating PD
  • preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
  • signed written informed consent

Who cannot join

  • a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
  • hypersensitivity to any component of the formulation
  • active severe infection/inflammation
  • history of transfusion, erythropoietin, >500 mg intravenous iron administration within 4 weeks prior to screening.
  • history of acquired iron overload.
  • MCV > 95µm3 or TSAT > 35%
Show all 10Show fewer
  • patients with preoperative Hb<7 g/dl
  • pregnancy or lactation
  • decreased renal function (defined as creatinine clearance <50 L/min/1.73m2calculated by eGFR(MDRD))
  • chronic liver disease or increase of liver enzymes (ALT, AST) >5 times the upper limit of normal range

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

Other trials in South Korea

About this study

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Read the detailed description

Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).

Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Being tested
Ferinject (Ferric Carboxymaltose)
Keywords
ferric carboxymaltose, Ferinject®, pancreatoduodenectomy
Medical subject headings
Pancreatic Neoplasms, Anemia

What participants receive

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

  • Ferinject (Ferric Carboxymaltose)Drug

    Also called Ferinject

    Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg .

    Study drug may be administered as IV drip infusion or IV undiluted bolus injection.

Study groups in NCT02628860
Study groupRoleWhat they receive
FerinjectExperimentalFerinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg . Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride. Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.
Receives: Drug: Ferinject (Ferric Carboxymaltose)

What is being measured

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

  1. Perioperative transfusion rate

    To evaluate reducing transfusion rate during perioperative period

    Measured: from preoperative baseline within the first 7 days after surgery

Secondary outcomes (3)

  1. Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications

    To investigate the association between the number of participants with complications and hospital length of stay(days)

    Measured: up to 4-6 weeks after surgery

  2. Change of hematology parameters

    change of hematology parameters value of Hb in g/dL,

    • ferritin in ng/ml
    • transferrin saturation in % (TSAT) after Ferinject® administration)

    Measured: up to 4-6 weeks after surgery

  3. Adverse event

    assessment of adverse effect with Ferinject® administration

    Measured: up to 4-6 weeks after surgery

Timeline

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

  1. First posted11 Dec 2015 (estimated)
  2. Study startJan 2014
  3. Primary completion27 Apr 2020
  4. Study completion27 Apr 2020

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02628860
Sponsor's protocol ID
NCCCTS-13-709
Acronym
FCM
Status last verified
Apr 2020
First submitted
5 Feb 2015
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Park SJ, Kim SW, Jang JY, Lee KU, Park YH. Intraoperative transfusion: is it a real prognostic factor of periampullary cancer following pancreatoduodenectomy? World J Surg. 2002 Apr;26(4):487-92. doi: 10.1007/s00268-001-0254-6. Epub 2002 Feb 4.

    PubMed 11910485

  • Yeh JJ, Gonen M, Tomlinson JS, Idrees K, Brennan MF, Fong Y. Effect of blood transfusion on outcome after pancreaticoduodenectomy for exocrine tumour of the pancreas. Br J Surg. 2007 Apr;94(4):466-72. doi: 10.1002/bjs.5488.

    PubMed 17330243

  • Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5.

    PubMed 1990875

  • Kaplan J, Sarnaik S, Gitlin J, Lusher J. Diminished helper/suppressor lymphocyte ratios and natural killer activity in recipients of repeated blood transfusions. Blood. 1984 Jul;64(1):308-10.

    PubMed 6234037

  • Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function. III. Alterations in macrophage arachidonic acid metabolism. Arch Surg. 1987 Jan;122(1):56-60. doi: 10.1001/archsurg.1987.01400130062009.

    PubMed 3492188

  • Innerhofer P, Tilz G, Fuchs D, Luz G, Hobisch-Hagen P, Schobersberger W, Nussbaumer W, Lochs A, Irschick E. Immunologic changes after transfusion of autologous or allogeneic buffy coat-poor versus WBC-reduced blood transfusions in patients undergoing arthroplasty. II. Activation of T cells, macrophages, and cell-mediated lympholysis. Transfusion. 2000 Jul;40(7):821-7. doi: 10.1046/j.1537-2995.2000.40070821.x.

    PubMed 10924610

  • Ghio M, Contini P, Mazzei C, Brenci S, Barberis G, Filaci G, Indiveri F, Puppo F. Soluble HLA class I, HLA class II, and Fas ligand in blood components: a possible key to explain the immunomodulatory effects of allogeneic blood transfusions. Blood. 1999 Mar 1;93(5):1770-7.

    PubMed 10029607

  • Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.

    PubMed 6125797

  • Griffin JF, Smalley SR, Jewell W, Paradelo JC, Reymond RD, Hassanein RE, Evans RG. Patterns of failure after curative resection of pancreatic carcinoma. Cancer. 1990 Jul 1;66(1):56-61. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-6.

    PubMed 2354408

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferinject (Ferric Carboxymaltose) in people with Pancreatic Cancer and Anemia, run by National Cancer Center, Korea at 1 site in South Korea.

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Perioperative transfusion rate (time frame: from preoperative baseline within the first 7 days after surgery). 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 NCT02628860, which also lists 9 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 28 Apr 2020.

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