Text Size

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

This study is currently recruiting participants.
Verified March 2013 by Jules Bordet Institute
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01658956
First received: July 27, 2012
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for unplanned hospitalization [ Time Frame: At the beginning of second chemotherapy cycle, no more than 30 days after randomization ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 142
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01658956     History of Changes
Other Study ID Numbers: Institut Jules Bordet
Study First Received: July 27, 2012
Last Updated: March 14, 2013
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
 Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013