Gynecologic CancerPhase 3FORGENCT05467319
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
A Phase 3 study testing Ferric Derisomaltose Injection and Normal saline in people with Gynecologic Cancer and Anemia, Iron Deficiency, run by Alberta Health Services, Calgary.
Trial summary
Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
- What is being tested?
- Ferric Derisomaltose Injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to Dec 2023
- Phase
- Phase 3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age and signed written informed consent
- 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[19].
- The expected time from recruitment to surgery is at least 28 days.
- Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20%
Show all 9Show fewer
- 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 (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)
- Laboratory data used for determination of eligibility 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 FDI or its excipients
- Temperature >38 C or patient on non-prophylactic antibiotics
- Known chronic liver disease or active hepatitis
- Received erythropoietin or IV iron therapy in previous 12 weeks
Show all 12Show fewer
- If LFT's are ordered, either clinically indicated or for chemotherapy, and screening alanine transaminase (ALT) or aspartate transaminase (AST) is 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)
- Unfit for elective surgery
- Pregnancy or lactation
- Unable to fully comprehend and/or perform study procedures
- Cervical cancer with a clinical stage of 2A or greater.
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 up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind 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. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.
- Conditions
- Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
- Being tested
- Ferric Derisomaltose Injection, Normal saline
- Keywords
- Ferric derisomaltose, iron isomaltoside, intravenous iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Derisomaltose InjectionDrug
Also called iron isomaltoside, Monoferric, Monofer
1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
Normal salineDrug
100 mL of 0.9% normal saline (w/v) by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Ferric derisomaltose | Experimental | 1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose. Receives: Drug: Ferric Derisomaltose Injection |
| Placebo | Placebo comparator | 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative hemoglobin level
Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
Measured: 0 to 3 days prior to planned surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start30 Sep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel groups, randomized placebo-controlled, double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health Services, Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S
- Responsible party
- Principal investigator, Steven Bisch, Alberta Health Services, Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467319
- Sponsor's protocol ID
- FORGEII
- Acronym
- FORGE
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. 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
- NCT05467319
- Acronym / sponsor ID
- FORGE / FORGEII
- Conditions
- Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
- Keywords
- Ferric derisomaltose, iron isomaltoside, intravenous iron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Alberta Health Services, CalgaryUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jul 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 up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind 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. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups, randomized placebo-controlled, double blind
| Arm | Type | Receives |
|---|---|---|
| Ferric derisomaltose | Experimental | Drug: Ferric Derisomaltose Injection1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose. |
| Placebo | Placebo comparator | Drug: Normal saline100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age and signed written informed consent
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- Screening haemoglobin less than 120g/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 (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)
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 FDI or its excipients
- Temperature >38 C 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 Derisomaltose InjectionAlso: iron isomaltoside, Monoferric, Monofer1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion | Drug | Ferric derisomaltose |
| Normal saline100 mL of 0.9% normal saline (w/v) by intravenous infusion | Drug | Placebo |
Primary outcome
Preoperative hemoglobin level
Time frame: 0 to 3 days prior to planned surgical intervention
Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Gynecologic Cancer
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Enrolling by invitation
Peer Ambassador in Gyn Onc Trials
Ovarian Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Derisomaltose Injection and Normal saline in people with Gynecologic Cancer and Anemia, Iron Deficiency, run by Alberta Health Services, Calgary.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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 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?
Results are not available in the source record.
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?
Preoperative hemoglobin level (time frame: 0 to 3 days prior to planned surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.