Prophylactic Use of Erythropoietin in patients receiving chemotherapy for cancer

Phase 3

Completed

• Conditions: Chemotherapy-associated anaemia; Cancer (solid tumors); Cancer - Any cancer; Blood - Anaemia

• Registration Number: ACTRN12614001082695
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Histologically confirmed cancer
-Hemoglobin more or equal to 11-13gr/dl
-Scheduled Treatment duration more than three months
-Age more or equal to 18 years
-Performance Status 0-2 (World Health Organisation)
-Negative Pregnancy Test
-Life Expectancy more or equal to 4 months
-Sufficiency of vitamin B12 (>200 pg/ml) or folic acid (>2.5 ng/ml)
-Sufficiency of iron (transferrin saturation >15%, ferritin >50 ng/ml)
-Signed informed consent
- Patients were to be scheduled to begin chemotherapy within 4 weeks after study enrolment

Exclusion Criteria

-Anaemia (Hb< 11 mg/dl) due to cancer
-Previous Erythropoietin Administration for any reason
-Scheduled Treatment duration less than three months
-Life Expectancy less than six months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ong-term Safety. This is a composite primary outcome. Toxicity and adverse events possibly related to the study drug (such as thrombosis, myocardial infarction, stroke, pulmonary embolism) were systemically recorded in every clinical visit and with complimentary laboratory or imaging tests upon clinical symptom alert. Clinical outcomes in terms of disease progression or death were also systemically recorded.[7 years after Randomization]

Secondary Outcome Measures

Name	Time	Method
Overall Survival [7 years after Randomization];Progression-Free Survival[7 years after Randomization]