- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658956
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)
January 5, 2015 updated by: Jules Bordet Institute
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
142
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1000
- Recruiting
- Institut Jules Bordet
-
Contact:
- Aspasia Georgala, MD
- Phone Number: 3225413255
- Email: aspasia.georgala@bordet.be
-
Contact:
- Marianne Paesmans
- Phone Number: 3225413399
- Email: marianne.paesmans@bordet.be
-
Principal Investigator:
- Aspasia Georgala, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Experimental: Subcutaneous GCSF 5 µg/kg days 8 and 12
Prophylactic administration of GCSF on days 8 and 12 following chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for unplanned hospitalization
Time Frame: At the beginning of second chemotherapy cycle, no more than 30 days after randomization
|
Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration
|
At the beginning of second chemotherapy cycle, no more than 30 days after randomization
|
Complicated febrile neutropenic episode
Time Frame: At the beginning of the second chemotherapy cycle, no more than 30 days after randomization
|
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
|
At the beginning of the second chemotherapy cycle, no more than 30 days after randomization
|
Mortality any cause
Time Frame: 30 days from randomization
|
30 days from randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
July 27, 2012
First Submitted That Met QC Criteria
August 2, 2012
First Posted (Estimate)
August 7, 2012
Study Record Updates
Last Update Posted (Estimate)
January 6, 2015
Last Update Submitted That Met QC Criteria
January 5, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Institut Jules Bordet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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