Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT05226169
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Intravenous Ferric Carboxymaltose for Iron-Deficiency Anemia in Patients With Advanced Gastric Cancer Receiving Palliative Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: