Gynecologic CancerPhase 3FORGE IINCT05407987
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
A Phase 3 study testing Ferric derisomaltose in people with Gynecologic Cancer and Anemia, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Anemia, Iron-deficiency
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2025to 30 Dec 2027
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 1. 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.
- 11. Cervical cancer with a clinical stage of 2A or greater.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Kan contact
Canada1 site, 1 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Steven Bisch, MD, 587-231-6204, Steven.Bisch@ahs.ca
Michelle Kan, michelle.kan@ahs.ca
About this study
Official title: Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
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
- Being tested
- Ferric derisomaltose, Placebo
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
Also called MONOFERRIC
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.
PlaceboDrug
Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean haemoglobin concentration (in g/L) at the time of surgery.
Measured: Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose
Mean postoperative haemoglobin concentration
The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean hemoglobin concentration after the completion of surgery which will be assessed by measuring blood hemoglobin levels
Measured: Haemoglobin concentration will be measured at 28 and 60 days after surgery
Assessment of the requirement of postoperative blood transfusion
The number of participants requiring blood transfusion after completion of gynecologic surgery. A blood transfusion event is defined as receiving any volume of one unit or more than one unit of packed red cells or whole blood.
Measured: Day 0 to 28 days following surgery
Mean number of blood transfusions
The mean number of blood transfusion (total number of units of packed red blood cells transfused ) after completion of gynecologic surgery
Measured: Day 0 to 28 days following surgery
Postoperative Quality of Recovery(QoR)-15 questionnaire score
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1 compared to baseline (minimum value : 0, maximum value : 150, the higher the score, the better the result)
Measured: Post-operation day 1 (24 hours ± 12 hours following surgery)
Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores
The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS.
Measured: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores
Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
Measured: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Mean Change in Quality of life measured with the SF-36 scores
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Minimum Value: 0 (worst outcome) Maximum Value: 100 (best outcome)
Measured: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Clinical surgical site infection
Rate of participants presenting with clinical surgical site infection will be measured post-operation.
Measured: within 28 days following surgery
Clinical surgical complications
Proportion of participants experiencing any complication post-operatively
Measured: within 28 days following surgery
Postoperative length of hospital stay
Mean and median length of stay (in days) in hospital following surgery
Measured: From Surgery date up to 60 days post surgery
Rate of hospital readmission
Proportion of participants requiring re-admission to hospital following surgery after initial discharge
Measured: from discharge date to 28 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start8 Apr 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407987
- Sponsor's protocol ID
- FORGE II
- Acronym
- FORGE II
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37945297
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05407987
- Acronym / sponsor ID
- FORGE II / FORGE II
- Conditions
- Gynecologic Cancer, Anemia, Iron-deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Therapy Arm | Experimental | Drug: Ferric derisomaltose500 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. |
| Placebo Arm | Placebo comparator | Drug: Placebo100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric derisomaltoseAlso: MONOFERRICFerric 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. | Drug | Iron Therapy Arm |
| PlaceboPatients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour. | Drug | Placebo Arm |
Primary outcome
Mean preoperative haemoglobin concentration
Time frame: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose
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.
12 secondary outcomes
Mean haemoglobin concentration at the time of surgery
Time frame: Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose
Mean postoperative haemoglobin concentration
Time frame: Haemoglobin concentration will be measured at 28 and 60 days after surgery
Assessment of the requirement of postoperative blood transfusion
Time frame: Day 0 to 28 days following surgery
Mean number of blood transfusions
Time frame: Day 0 to 28 days following surgery
Postoperative Quality of Recovery(QoR)-15 questionnaire score
Time frame: Post-operation day 1 (24 hours ± 12 hours following surgery)
Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores
Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores
Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Mean Change in Quality of life measured with the SF-36 scores
Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Clinical surgical site infection
Time frame: within 28 days following surgery
Clinical surgical complications
Time frame: within 28 days following surgery
Postoperative length of hospital stay
Time frame: From Surgery date up to 60 days post surgery
Rate of hospital readmission
Time frame: from discharge date to 28 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 37945297Bisch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Kan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric derisomaltose in people with Gynecologic Cancer and Anemia, run by AHS Cancer Control Alberta at 1 site in Canada.
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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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 Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Steven Bisch, MD (403-521-3721, Steven.Bisch@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean preoperative haemoglobin concentration (time frame: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose). 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 NCT05407987, which also lists 1 linked publication.
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 Oct 2026.