Trial Title:
Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer
NCT ID:
NCT06248749
Condition:
Anaemia in Ovarian Carcinoma
Conditions: Official terms:
Anemia
Iron
Ferric Oxide, Saccharated
Iron isomaltoside 1000
Ferric gluconate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is an open label, prospective, randomized [1:1] controlled, Phase III study of Iron
Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion
treatment (Control group B) in participants diagnosed with ovarian cancer and with iron
deficiency anemia. The primary objective of the study is to assess the efficacy of iron
infusion, as measured by the primary endpoint, of Group A versus Group B.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IV iron
Description:
Intravenous Iron supplement
Arm group label:
Iron Infusion Arm
Other name:
iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)
Summary:
Cancer related anemia (CRA) is a common sign occurring in more than 30% of patients at
diagnosis, prior to initiation of antineoplastic therapy. Anemia is known to impact
survival, disease progression, treatment efficacy, and the patient's quality of life.
Proinflammatory cytokines, mainly IL-6, which are released by both tumor and immune
cells, play a pivotal action in CRA etiopathogenesis: they promote alterations in
erythroid progenitor proliferation, erythropoietin (EPO) production, survival of
circulating erythrocytes, iron balance, redox status, and energy metabolism, all of which
can lead to anemia. Chronic inflammatory conditions such as cancer influences a
compromised nutritional status, which in-turn may contribute to anemia.
This study aims to study the role of intravenous (IV) iron infusion in the management of
anemia presented in patients previously treated or currently being treated for ovarian
cancer. The study aims to identify the safety and efficacy of IV iron infusion on anemia
in ovarian cancer patients, and the effect on quality of life and overall survival
Detailed description:
This is an open label, prospective, randomized [1:1] controlled, Phase III study of Iron
Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion
treatment (Control group B) in participants diagnosed with ovarian cancer and with iron
deficiency anemia. The primary objective of the study is to assess the efficacy of iron
infusion, as measured by the primary endpoint, of Group A versus Group B.
The study treatment is divided into two groups (Arms):
Group A: Treatment study group
All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT <
20%. Blood transfusion may also be given based on physician's discretion whenever
indicated:
1. When Hgb level is < 70 g/L or in case of emergency and/or rapid blood loss.
2. Blood transfusion may be given to keep active treatment (chemotherapy, surgery, PARP
inhibitors, hormonal, radiation) intervals as scheduled and not to exceed the
maximum 4 weeks.
3. Based on current practice and NCCN guidelines, co-investigators/treating physicians
are encouraged to avoid giving blood transfusion for Hgb >70g/L, provided the
patient is stable and asymptomatic.
4. Blood transfusion can be combined with iron infusion.
5. Blood transfusion can be given when indicated if there is lack of response to iron
infusion. Expected iron infusion response is expected at 8 weeks or less after
treatment (from the preceding dose of a single IV iron order/treatment). For
example, Isomatoside, monoferric is given as one dose, where iron gluconate is
fractionated over 6 doses and iron sucrose is fractionated into 3 doses.
Group B: Control group
1. May receive blood transfusion when Hgb level is <70 g/L or in case of emergency
and/or rapid blood loss.
2. Based on current practice and NCCN guidelines, co-investigators/treating physicians
are encouraged to avoid giving blood transfusion for Hgb >70 g/L, provided the
patient is stable and asymptomatic.
3. The decision to give blood transfusion for Hgb >70 g/L shall be based on the
treating physician's discretion:
1. symptomatic patient
2. to maintain active treatment schedule
3. to prepare the patient for surgery or an interventional procedure
Criteria for eligibility:
Criteria:
INCLUSION CRITERIA:
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Age and Sex: Female participants aged 18 years or more (>/=18 years) at the time of
informed consent.
2. Type of Participant: Participants who are willing and able to comply with all
scheduled visits, laboratory tests, lifestyle considerations, treatment plan, and
any other study procedures.
3. Disease Characteristics: Histologically confirmed primary epithelial invasive
ovarian cancer of any grade, including serous, mucinous, endometrioid, clear cell,
transitional, squamous and carcinosarcoma. Cancer must be FIGO stage IC-IV.
4. Presence of measurable disease per RECIST v1.1, as assessed by investigator and
evidenced by available baseline tumor scan. At least 1 target lesion of 10mm.
Note: Baseline Scan is defined as the last scan prior to the date of randomization.
5. Patients should be eligible for active cancer treatment ECOG less or equal to 2 and
life expectancy must be more than 6 months.
6. Received no more than two (2) systemic lines of chemotherapy (to allow for a ~3
years follow up).
7. Patients on any active cancer treatment or with history of previous chemotherapy,
surgery, radiation, PARP (Poly-ADP Ribose polymerase), biologics and hormonal
treatment.
8. Patients on neoadjuvant, adjuvant, advanced cancer treatment.
9. Perioperative patients having upfront surgery (can be randomized after frozen
section) or at interval or secondary debulking surgery.
10. Informed Consent: Capable of giving signed informed consent.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. Patients would not consent for IV iron infusion or blood transfusion (Example:
Jehovah's Witness).
2. History of known severe hypersensitivity to IV iron transfusion with the study iron
products.
3. Medical conditions with contraindication to IV iron infusion or blood transfusion
(Example:
iron overload, hemosiderosis, decompensated liver cirrhosis or active hepatitis.)
4. Palliative patients with life expectancy 6 months or less.
Gender:
Female
Gender based:
Yes
Gender description:
biological female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Allan Blair Cancer Centre
Address:
City:
Regina
Zip:
S4T 7T1
Country:
Canada
Contact:
Last name:
Maryam Al-Hayki
Phone:
3067662213
Email:
maryam.al-hayki@saskcancer.ca
Investigator:
Last name:
Maryam Al-Hayki
Email:
Principal Investigator
Investigator:
Last name:
Shaina Lee
Email:
Sub-Investigator
Investigator:
Last name:
Brent Jim
Email:
Sub-Investigator
Facility:
Name:
Saskatoon Cancer Centre
Address:
City:
Saskatoon
Zip:
S7N 4H4
Country:
Canada
Contact:
Last name:
Maryam Al-Hayki
Phone:
3067662213
Email:
maryam.al-hayki@saskcancer.ca
Investigator:
Last name:
Maryam Al-Hayki
Email:
Principal Investigator
Investigator:
Last name:
Laura Hopkins
Email:
Sub-Investigator
Investigator:
Last name:
Vickie Martin
Email:
Sub-Investigator
Investigator:
Last name:
Jennifer Brown Broderick
Email:
Sub-Investigator
Start date:
February 29, 2024
Completion date:
December 1, 2029
Lead sponsor:
Agency:
University of Saskatchewan
Agency class:
Other
Source:
University of Saskatchewan
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248749
