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

NCT ID: NCT01658956

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-07-31

Brief Summary

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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 Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Subcutaneous GCSF 5 µg/kg days 8 and 12

Prophylactic administration of GCSF on days 8 and 12 following chemotherapy

Group Type EXPERIMENTAL

GCSF administration on days 8 and 12 after chemotherapy

Intervention Type DRUG

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GCSF administration on days 8 and 12 after chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Aspasia Georgala, MD

Role: primary

3225413255

Marianne Paesmans

Role: backup

3225413399

Other Identifiers

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Institut Jules Bordet

Identifier Type: -

Identifier Source: org_study_id

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