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Trial registered on ANZCTR


Registration number
ACTRN12614001082695
Ethics application status
Approved
Date submitted
25/07/2014
Date registered
9/10/2014
Date last updated
9/10/2014
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285040 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-associated anaemia 292552 0
Cancer (solid tumors) 293024 0
Condition category
Condition code
Cancer 292859 292859 0 0
Any cancer
Blood 293295 293295 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289874 0
Treatment: Drugs
Intervention code [2] 289875 0
Prevention
Comparator / control treatment
Hemoglobin-based Erythropoietin administration (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 the first time that the value of Hb is <11gr/dl and continues with a target of 13 mg/dl, at which point Erythropoietin support is discontinued, only to be resumed if hemoglobin levels fall again below 11 mg/dl.

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.
Control group
Active

Outcomes
Primary outcome [1] 292734 0
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.
Timepoint [1] 292734 0
7 years after Randomization
Secondary outcome [1] 309571 0
Overall Survival
Timepoint [1] 309571 0
7 years after Randomization
Secondary outcome [2] 310649 0
Progression-Free Survival
Timepoint [2] 310649 0
7 years after Randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6244 0
Greece
State/province [1] 6244 0

Funding & Sponsors
Funding source category [1] 289646 0
Other Collaborative groups
Name [1] 289646 0
Hellenic Cooperative Oncology Group
Address [1] 289646 0
18, Hatzikostandi str, 11524, Athens
Country [1] 289646 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
Hatzikostandi 18, 11524, Athens
Country
Greece
Secondary sponsor category [1] 288338 0
None
Name [1] 288338 0
Address [1] 288338 0
Country [1] 288338 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study aims to compare prophylactic versus hemoglobin-based
erythropoietin administration in patients receiving cytotoxic chemotherapy for early or advanced cancer. Eligible patients are randomized in two groups: Patients in Group A (experimental arm) receive prophylactic ESA (epoetin A, 10.000IU x 3 times weekly, subcutaneous infusion) with iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) with a target hemoglobin level of 14 mg/dl. If hemoglobin levels exceed this threshold, ESA administration is discontinued and is resumed when hemoglobin levels fell under 12 mg/dl.
In group B, patients receive only iron supplementation (Resoferon 10mg daily per os or Legofer 10mg, taken in 2 drinking ampoules) and ESA administration is initiated if hemoglobin levels fall below 11 mg/dl and are continued with a target of 13 mg/dl, at which point ESA support is discontinued, only to be resumed if hemoglobin levels fall again below 11 mg/dl. In both groups ESA administration is to be continued for four weeks after cessation of chemotherapy. The primary end-point of the study is safety, with emphasis on a composite outcome of thrombosis-related adverse events, while secondary endpoints include progression-free survival and overall survival.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 50146 0
Dr Gerasimos Aravantinos
Address 50146 0
Second Department of Medical Oncology, “Agii Anargiri” Cancer Hospital, Noufaron & T. Stavrou, 14564, Kaliftaki, Athens
Country 50146 0
Greece
Phone 50146 0
+302103501283
Fax 50146 0
Email 50146 0
bpstudies@yahoo.gr
Contact person for public queries
Name 50147 0
Ms Maria Moschoni
Address 50147 0
Hellenic Cooperative Oncology Group, 18, Hatzikostandi str, 11524, Athens
Country 50147 0
Greece
Phone 50147 0
+302106912520
Fax 50147 0
Email 50147 0
m_moschoni@hecog.ondsl.gr
Contact person for scientific queries
Name 50148 0
Dr Giannis Mountzios
Address 50148 0
251 General Airforce Hospital
Riga Ferraiou 38 str, 15451, Athens
Country 50148 0
Greece
Phone 50148 0
+302107463905
Fax 50148 0
+302107715690
Email 50148 0
gmountzios@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary