The Effect Of Intravenous Iron In Treating Anemia In Ovarian Cancer Patients In Saskatchewan: A Phase-III, Open-Label, Randomized Trial (IIOVS-01)

IIOVS-01

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

2024-02-29

2028-12-01

2029-12-01

Not yet recruiting

Early phase I

200

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-02-08