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Pilot feasibility study of Ferinject® in patients with esophageal cancer

Pilot feasibility study of Ferinject® in patients with esophageal cancer - ARCHIE-1

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37387
Enrollment
20
Registered
2013-07-16
Start date
2012-09-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anemia

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Potentially operable and resectable patients with esophageal cancer - Age 18 year and older - Hb < 7.5 mmol/L in women and Hb < 8.1 mmol/L in men - TSAT < 20%, Ferritine < 100 µg/L * absolute iron deficiency - TSAT < 20%, Ferritine > 100 µg/L * functional iron deficiency

Exclusion criteria

Exclusion criteria: - T4 carcinomas - Inoperable due to comorbidity or ASA IV - Irresectability - Metastasis - Erythropoiesis stimulating agents within 3 months before screening - Ferritine > 500 µg/L

Design outcomes

Primary

MeasureTime frame
Primary Endpoint: Number of Hb responders - Hb responder: increase in Hb * 1.2 mmol/L or reaching normal value normal value Hb (Hb = 7.5 mmol/L in women and Hb = 8.1 mmol/L in men within 3 weeks after start of treatment - SAE's van Ferinject®—

Secondary

MeasureTime frame
Secondary Endpoints - The number of blood transfusions peri-operative - (S)AE*s (using Vifor Pharma forms) - Shorter hospital stay due to participation in fast track recovery during admission - Quality of life (using the SF-36 questionnaire) during every timepoint starting from treatment - Increased Hb levels during every timepoint starting from treatment—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)