ASTRON (OGSG 2401) study protocol: Ferric carboxymaltose for iron deficiency anemia in gastrointestinal cancer.

INTRODUCTION

Anemia presents a significant challenge in gastrointestinal cancer patients undergoing chemotherapy, adversely affecting qualityof life and treatment continuity. Conventional treatments such as red bloodcell transfusions, erythropoiesis-stimulating agents, and oral iron have limitations, including thrombosis risk, supply constraints,and poor tolerability.

AREAS COVERED: Ferriccarboxymaltose (FCM) IFON_A_2569574 forcontrolled uptake, enabling safe administration of large doses. Thisprospective multicenter study evaluates FCM for managing iron deficiency anemiain patients with unresectable or recurrent gastric or colorectal cancerreceiving chemotherapy. The protocol involves administering 1500 mg of FCM inthree 500 mg doses, each given at least 7 days apart and all within 29 daysfrom the first dose (Day 1). The primary endpoint is the rate of hemoglobinimprovement at 8 weeks. A sample size of 50 patients was calculated to detect a33% improvement rate against a 15% threshold with 80% power.Secondary endpoints include hemoglobin improvement rates at 4 and 12 weeks, andQoL assessment at 4, 8, and 12 weeks.

EXPERT OPINION/COMMENTARY: We anticipate thatour findings will support anemia management in this patient population.

CLINICALTRIAL REGISTRATION: jRCTs051240288.