gastric cancer and colorectal cancer
Conditions
Interventions
Ferric carboxymaltose
Sponsors
YAMAGUCHI Toshifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with adenocarcinoma of the stomach or colon by histopathology. 2) Undergoing chemotherapy for unresectable or recurrent disease and expected to continue. Chemotherapy includes cytotoxic anticancer drugs, molecular targeted agents, and immune checkpoint inhibitors. Patients receiving monotherapy are eligible. Patients receiving postoperative chemotherapy are excluded. 3) Has anemia (Hb less than 10.0 g/dL). 4) Has transferrin saturation (TSAT) less than 20%. Transferrin Saturation (TSAT, %) = Serum Iron (Fe)/Total Iron Binding Capacity (TIBC) * 100 5) Age 20 years or older at the time of registration. 6) PS 0-2. 7) Weight 35 kg or more. 8) Oral intake ability. 9) Expected to continue chemotherapy for 12 weeks or more. 10) Expected survival of 6 months or more. 11) Has not taken oral iron supplements (including over-the-counter drugs) within 4 weeks (28 days) from the date of blood test at registration. 12) Has not received intravenous iron, blood products, erythropoiesis-stimulating agents (ESA), iron chelators, progestins, gonadotropin-releasing hormone agonists/antagonists, or ethisterone derivatives within 8 weeks (56 days) from the date of the blood test at registration. 13) Written informed consent has been obtained from the patient to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1) Active bleeding requiring blood transfusion or hemostatic intervention. 2) Hb level less than 7.0 g/dL. 3) Symptomatic brain metastasis or leptomeningeal metastasis. 4) Hematopoietic stem cell abnormalities, globin synthesis disorders, increased red blood cell destruction, impaired red blood cell production, or renal anemia. 5) Active bacterial or fungal infection (body temperature of 38 degrees C or higher). 6) Psychiatric disorders or symptoms that make participation in the study difficult. 7) The principal investigator or sub-investigator determines that treatment with blood transfusion should be prioritized. 8) Deemed inappropriate by the principal investigator or sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hemoglobin improvement at 8 weeks from initial administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of hemoglobin improvement at 4 and 12 weeks from initial administration Quality of life (FACT-An Score and EQ-5D) at 4, 8, and 12 weeks from initial administration Transitions in hematological parameters (hemoglobin, TSAT, serum iron, and ferritin) at baseline and at 4, 8, and 12 weeks from initial administration, and the rate of blood transfusion. | — |
Contacts
Public ContactHiroki YUKAMI
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed