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Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Jules Bordet Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658956
First Posted: August 7, 2012
Last Update Posted: January 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jules Bordet Institute
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: GCSF administration on days 8 and 12 after chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

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) [ Time Frame: At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization ]

Secondary Outcome Measures:
  • 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

  • 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

  • Mortality any cause [ Time Frame: 30 days from randomization ]

Estimated Enrollment: 142
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subcutaneous GCSF 5 µg/kg days 8 and 12
Prophylactic administration of GCSF on days 8 and 12 following chemotherapy
Drug: GCSF administration on days 8 and 12 after chemotherapy
No Intervention: No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658956


Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Aspasia Georgala, MD    3225413255    aspasia.georgala@bordet.be   
Contact: Marianne Paesmans    3225413399    marianne.paesmans@bordet.be   
Principal Investigator: Aspasia Georgala, MD         
Sponsors and Collaborators
Jules Bordet Institute
  More Information

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01658956     History of Changes
Other Study ID Numbers: Institut Jules Bordet
First Submitted: July 27, 2012
First Posted: August 7, 2012
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Jules Bordet Institute:
GCSF
Chemotherapy
Breast cancer
Prophylaxis

Additional relevant MeSH terms:
Neutropenia
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases