Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
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|ClinicalTrials.gov Identifier: NCT05226169|
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : May 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Carcinoma||Drug: Ferinject Other: Conservative management||Phase 3|
Gastric cancer is associated with chronic blood loss, poor nutrition, and surgical interventions interfering with iron absorption, all of which synergistically increase the risk of iron-deficiency anemia (IDA). A retrospective review of gastric cancer reported that at the time of gastric cancer diagnosis, the prevalence of anemia was 58.7% and the overall prevalence of IDA was 40%. Moreover, patients with unresectable locally advanced or metastatic gastric cancer are treated with myelosuppressive chemotherapies, which further increases the risk for anemia.
The absorption of oral iron in gastric cancer patients is limited due to malabsorption, ongoing gastrointestinal bleeding, and lack of adherence to treatment due to dyspepsia, vomiting, abdominal pain, diarrhea, and constipation. Therefore, IV iron may be preferable due to easy administration, effective iron absorption, and infrequent complications in gastric cancer patients.
• There are a number of IV iron formulations in the market; the recommended IV iron preparations are low-molecular-weight iron dextran, ferric gluconate, iron sucrose, ferric carboxymaltose (FCM), and ferumoxytol. FCM (FerinjectTM; Vifor Pharma, Glattbrugg, Switzerland) is a stable colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose, which allows slow and prolonged iron release, and is given as a single high-dose (1,000 mg of iron) in a 15-minute infusion. Based on extensive experience in clinical trial and real-world settings, IV FCM is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anemia in patients with ID or IDA of various etiologies.
FCM was effective in patients with active malignancy and IDA (n=420), and hematological malignancies or solid tumors and anemia (n=367) in two real-world, noninterventional studies conducted in Germany and France. Recently, two prospective studies conducted in South Korea have reported a significant increase in Hb levels by treatment with IV FCM in patients with solid cancers (including gastric cancer) receiving chemotherapy and in patients with acute isovolemic anemia following gastrectomy.
Therefore, the main objective of this study is to evaluate the efficacy and safety of IV FCM 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy|
|Actual Study Start Date :||April 29, 2022|
|Estimated Primary Completion Date :||November 30, 2024|
|Estimated Study Completion Date :||November 30, 2024|
Experimental: Active treatment arm : IV FCM
Intravenous ferric carboxymaltose
Other Name: IV FCM
Active Comparator: Control treatment arm: Conservative management
Other: Conservative management
- Maximum change of Hb concentration [ Time Frame: baseline to 12 weeks ]Maximum change of Hb concentration from baseline to 12 weeks (or first RBC transfusion and/or ESA, or study withdrawl, or death, whichever will be first) without RBC transfusion and/or ESA
- Change of Hb concentration [ Time Frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks ]Change of Hb concentration from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
- Change in serum iron [ Time Frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks ]Change in serum iron from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
- Change in serum ferritin [ Time Frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks ]Change in serum iron, ferritin(ng/dL) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
- Change in serum TIBC [ Time Frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks ]Change in serum TIBC(µg/dL) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
- Change in serum TSAT [ Time Frame: baseline to 3, 6, 9, 12, 24, 36, and 48 weeks ]Change in serum TSAT(%) from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks
- Tumor response [ Time Frame: every 6-8weeks, assessed up to 24 months ]according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]time from the date of first administration of palliative first-line chemotherapy to the date of the first objectively documented tumor progression or death, whichever occurs first)
- OS [ Time Frame: through study completion, an average of 2 years ]time from the date of first administration of palliative first-line chemotherapy to the date of death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226169
|Contact: Min-Hee Ryu, PhDemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Min-Hee Ryu, MD., Ph.D. +82-10-5285-9492 firstname.lastname@example.org|
|Principal Investigator: Min-Hee Ryu, M.D., Ph.D.|