Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Trial acronym
FeRIC (Fe dEficiency in ColoRectal Cancer)
Clinical summary
Summary
Eligible patients will be randomly (by chance) allocated to receive an infusion enriched with 1000mg iron (Ferric Carboxymaltose) OR a saline solution of similar appearance. All participants will receive maximum of 250mls of 0.9% saline solution with or without iron (depending on group) over a 15 minute period. All patients will be monitored for 30 minutes following completion of the infusion. No further blood tests will be required on the day of the infusion.
Conditions
This trial is treating people with colorectal cancer
Eligibility
Inclusion
1. Patients 18 years of age and older
2. Patients with histologically confirmed colorectal cancer presenting to Peter MacCallum Cancer Centre, or Epworth Hospital (Richmond and Eastern campuses).
3. Ferritin <100mcg/l or 100-300mcg/L and TSAT<20%
4. Normal Serum Vitamin B12 and Folate levels
5. Normal red cell folate and B12 levels
6. Patients planned for surgery colorectal surgery
Exclusion
1. Hb (>130mg/dL male, or >120mg/dL female) & (either one of: Ferritin >300mcg/l, or Ferritin >100mcg/l and TSAT >20%)
2. Marked Iron deficiency anaemia precluding randomization: Hb < 110 mg/dL & Ferritin <20 mcg/l
3. Iron therapy contraindicated
4. Treatment with iron therapy or blood transfusion in the previous 12 weeks
5. Presentation for neoadjuvant CRT or Surgery within the study period
6. Patients with a known haematological abnormality (such as haemochromatosis or thalassemia, TSAT >50%)
7. Liver disease where ALT is above 3 times the upper limit of the normal range
8. Patients with a history of acquired iron overload or iron storage disorders
9. Previous hypersensitivity or allergic reactions to parentral (polymaltose/carboxymaltose) iron preparations
10. Patients unable to give informed consent
11. Physical disability preventing CPX, or contraindication in local CPX policy (such as angina at rest)
12. Patients included in other clinical trials that involve the administration of iron therapy
13. Blood transfusion in previous three months
Exclusion
- You have certain types of non-cancer medical conditions.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Peter MacCallum Cancer Centre
Scientific Title
An iron infusion with Ferric Carboxymaltose as a technique of improving physiological reserve in iron deficient patients undergoing surgery for colorectal cancer: a randomized control trial
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information