Back to resultsEffectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
GCSF administration on days 8 and 12 after chemotherapy
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring GCSF, Chemotherapy, Breast cancer, Prophylaxis
Eligibility Criteria
Inclusion Criteria:
Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant
Exclusion Criteria:
Eligibility to receive reimbursed GCSF
Sites / Locations
- Institut Jules BordetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Subcutaneous GCSF 5 µg/kg days 8 and 12
No intervention
Arm Description
Prophylactic administration of GCSF on days 8 and 12 following chemotherapy
Outcomes
Primary Outcome Measures
Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)
Secondary Outcome Measures
Need for unplanned hospitalization
Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration
Complicated febrile neutropenic episode
A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051
Mortality any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658956
Brief Title
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia
Acronym
PAPALDO
Official Title
A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
GCSF, Chemotherapy, Breast cancer, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subcutaneous GCSF 5 µg/kg days 8 and 12
Arm Type
Experimental
Arm Description
Prophylactic administration of GCSF on days 8 and 12 following chemotherapy
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
GCSF administration on days 8 and 12 after chemotherapy
Primary Outcome Measure Information:
Title
Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)
Time Frame
At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization
Secondary Outcome Measure Information:
Title
Need for unplanned hospitalization
Description
Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration
Time Frame
At the beginning of second chemotherapy cycle, no more than 30 days after randomization
Title
Complicated febrile neutropenic episode
Description
A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051
Time Frame
At the beginning of the second chemotherapy cycle, no more than 30 days after randomization
Title
Mortality any cause
Time Frame
30 days from randomization
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant
Exclusion Criteria:
Eligibility to receive reimbursed GCSF
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aspasia Georgala, MD
Phone
3225413255
Email
aspasia.georgala@bordet.be
First Name & Middle Initial & Last Name & Degree
Marianne Paesmans
Phone
3225413399
Email
marianne.paesmans@bordet.be
First Name & Middle Initial & Last Name & Degree
Aspasia Georgala, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia
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