Clinical Trial: Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: Jules Bordet Institute
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Jules Bordet Institute
Dates:
Date Received: July 27, 2012
Date Started: July 2012
Date Completion: July 2015
Last Updated: January 5, 2015
Last Verified: January 2015
