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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658956

Acronym

PAPALDO

Enrollment

142

Registered

2012-08-07

Start date

2012-07-31

Completion date

2015-07-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

GCSF, Chemotherapy, Breast cancer, Prophylaxis

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.

Interventions

DRUGGCSF administration on days 8 and 12 after chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

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)	At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization

Secondary

Measure	Time frame	Description
Need for unplanned hospitalization	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	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	30 days from randomization	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026