Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
The main objective of this study is to evaluate the efficacy and safety of IV FCM(ferric carboxymaltose) in patients with AGC receiving palliative chemotherapy. This study will also evaluate the effect of IV FCM on the treatment outcomes of palliative chemotherapy in patients with gastric cancer receiving fluoropyrimidine and platinum-based regimen in the same 1st-line palliative setting.
• Age ≥ 19 years at the time of study registration
• Eastern Cooperative Oncology Group performance status ≤ 2
• Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
• Locally advanced unresectable or metastatic disease
• Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma
• Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy
• Life expectancy ≥24 weeks
• IDA
‣ Hb 8 to \<11 g/dL
⁃ Absolute ID (serum ferritin \< 100 ng/mL) OR functional ID (TSAT\* \< 50% and serum ferritin 100-500 ng/mL)
∙ TSAT = (serum iron level x 100)/ total iron-binding capacity (TIBC)