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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01658956
• Other study ID #: Institut Jules Bordet
• Status: Recruiting
• Phase: Phase 2
• First received: July 27, 2012
• Last updated: January 5, 2015
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• GCSF administration on days 8 and 12 after chemotherapy

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization	No
Secondary	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	At the beginning of second chemotherapy cycle, no more than 30 days after randomization	Yes
Secondary	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	At the beginning of the second chemotherapy cycle, no more than 30 days after randomization	No
Secondary	Mortality any cause		30 days from randomization	Yes