Prophylactic Use of Erythropoietin in patients receiving chemotherapy for cancer

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001082695
• Date of registration: 09/10/2014
• Prospective Registration: No
• Primary sponsor: Hellenic Cooperative Oncology Group
• Public title: Prophylactic Use of Erythropoietin in patients receiving chemotherapy for cancer
• Scientific title: Randomized, Phase III Multicenter Trial of prophylactic versus Haemoglobin-based Erythropoietin administration for chemotherapy-associated anaemia in patients with solid tumors
• Date of first enrolment: 07/01/2002
• Target sample size: 800
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001082695.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Phase 3

Countries of recruitment

Greece

Contacts

• Name: Dr Giannis Mountzios

• Name: Ms Maria Moschoni

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Chemotherapy-associated anaemia;Cancer (solid tumors);
Chemotherapy-associated anaemia
Cancer (solid tumors)

Cancer - Any cancer

Blood - Anaemia

Intervention(s)

Prophylactic use of Erythropoietin-A, (epoetin-A 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily orally or Legofer 10mg, taken daily in 2 drinking ampoules, participant preference). The administration begins at chemotherapy initiation and continues until the value of Hb is >=14 gr/dl . The administration of Erythropoietin begins again when the value of Hb is <=12 gr/dl. The dose remains the same.

The administration of Erythropoietin ends 4 weeks after the last cycle of chemotherapy.
Daily iron treatment continues thoughout the intervention period regardless of Hb levels.

Primary Outcome(s)

Long-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(s)

Overall Survival [7 years after Randomization]

Progression-Free Survival[7 years after Randomization]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Hellenic Cooperative Oncology Group