Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

NCT05407987 | Recruiting Phase 3 DMC

• 1 other identifier: FORGE II
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates. This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia. The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.

Conditions

Gynecologic Cancer; Anemia; Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Mean preoperative haemoglobin concentration

  To determine the effect of IV iron supplementation provided at least 21 days prior to surgery for gynecologic malignancy on mean preoperative haemoglobin concentration (in g/L)in patients with iron deficiency anemia compared to those patients without preoperative IV iron supplementation.

  Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose

Secondary Outcomes (12)

• Mean haemoglobin concentration at the time of surgery

  Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose

• Mean postoperative haemoglobin concentration

  Haemoglobin concentration will be measured at 28 and 60 days after surgery

• Assessment of the requirement of postoperative blood transfusion

  Day 0 to 28 days following surgery

• Mean number of blood transfusions

  Day 0 to 28 days following surgery

• Postoperative Quality of Recovery(QoR)-15 questionnaire score

  Post-operation day 1 (24 hours ± 12 hours following surgery)

Study Arms (2)

Iron Therapy Arm

EXPERIMENTAL

500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.

Drug: Ferric derisomaltose

Placebo Arm

PLACEBO COMPARATOR

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Drug: Placebo

Interventions

Ferric derisomaltose DRUG

Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention.

Also known as: MONOFERRIC

Iron Therapy Arm

Placebo DRUG

Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years old.
• The indication for the operation may be for suspected or proven gynecologic malignancy.
• Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.
• The expected time from recruitment to surgery is 28-90 days.
• Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%.
• Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
• Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
• WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
• Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks.

You may not qualify if:

• Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%.
• Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
• Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
• Temperature \>38C or patient on non-prophylactic antibiotics.
• Known chronic liver disease or active hepatitis.
• Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
• Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.
• Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).
• Unfit for elective surgery.
• Pregnancy or lactation.
• \. Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.
• \. Cervical cancer with a clinical stage of 2A or greater.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Related Publications (1)

• Bisch SP, Woo L, Ljungqvist O, Nelson G. Ferric derisomaltose and Outcomes in the Recovery of Gynecologic oncology: ERAS (Enhanced Recovery After Surgery) (FORGE) - a protocol for a pilot randomised double-blinded parallel-group placebo-controlled study of the feasibility and efficacy of intravenous ferric derisomaltose to correct preoperative iron-deficiency anaemia in patients undergoing gynaecological oncology surgery. BMJ Open. 2023 Nov 9;13(11):e074649. doi: 10.1136/bmjopen-2023-074649.

  PMID: 37945297 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Steven Bisch, MD

CONTACT

403-521-3721; Steven.Bisch@ahs.ca

Michelle Kan

CONTACT

michelle.kan@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)