Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

NCT ID: NCT02816112

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-04-30

Brief Summary

Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.

The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.

Conditions

Early Stage Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin

Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC

Group Type: ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type: DRUG

Antibiotic

G-CSF

Daily injection at home for the number of days as chosen by the treating physician

Group Type: ACTIVE_COMPARATOR

Neupogen

Intervention Type: DRUG

Granulocyte-colony stimulating factor

Interventions

Ciprofloxacin

Antibiotic

Intervention Type: DRUG

Neupogen

Granulocyte-colony stimulating factor

Intervention Type: DRUG

Other Intervention Names

filgrastim

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed primary breast cancer
• Planned TC chemotherapy
• ≥19 years of age
• Able to provide verbal consent

Exclusion Criteria

• Contraindication to either Ciprofloxacin or G-CSF

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Clemons, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

OTT 16-03

Identifier Type: -

Identifier Source: org_study_id