Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer (EPIC)

July 20, 2018 updated by: Centre Henri Becquerel

Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer

Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age > 18
  • Documented breast cancer
  • No Her2 overexpression
  • Patients operated with curative intent (no distant metastasis at diagnosis)
  • Patients undergoing an adjuvant chemotherapy consisting of 3 courses of FEC 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of Taxotere, or 6FEC100 (according to CHB refencial for localised breast cancer treatment).
  • Signed informed consent

Exclusion Criteria:

  • Bilateral axillary node dissection
  • History of bilateral upper thoracic irradiation
  • Cutaneous disease (eczema, scleroderma, infection…) at catheter insertion site (arm or upper thorax)
  • Recent thrombosis of the upper body
  • Therapeutic anticoagulation
  • Tracheotomy
  • Treatment for bacteriemia in process
  • Altered hemostasis: INR > 1.5 ; APTT > 1.5 , platelets < 60 G/l
  • Renal failure with creatinine clearance < 60mL/min
  • Involvement in another trial
  • Contraindication to chemotherapy by FEC 100 or taxotere
  • Pregnancy or breast feeding
  • Protected major patient (under guardianship).
  • Psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICC line
Use of a PICC line for chemo administration (PowerPICC SOLO²)
Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)
The description of the device could found on the published marketing authorisation
Other Names:
  • kit PowerPICC SOLO² (Bard Access Systems Inc)
Active Comparator: Implanted Port
Use of an implanted port for chemo administration
Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)
The description of the device could found on the published marketing authorisation
Other Names:
  • kit PowerPICC SOLO² (Bard Access Systems Inc)
Device: implanted port for chemo administration (X-port isp)
Other Names:
  • X-port isp M.R.I Implantable Port (Bard Access Systems Inc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probability of occurrence of a significant adverse event related to the central venous device
Time Frame: 37 weeks
To define between the two device (PICC line and implanted port) which one provides the less probability of occurrence of a significant adverse event related to the device (SAERD), from the insertion to the first consultation of survey (36-38 weeks after implantation of the device which is also 5 months after its ablation).
37 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' satisfaction for the use of their central venous device
Time Frame: 1 year
Evaluation of the patients' satisfaction assessed by the QLQ C30, and by a 19 questions home-made questionnaire dedicated to the use of central veinous devices
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Florian Clatot, MD, Centre Henri Becquerel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 20, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB 13-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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