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REaCT-vascular Access Her2 Negative Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab (OTT 15-07)

This study is currently recruiting participants.
Verified October 2017 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02688998
First Posted: February 23, 2016
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose

In the REaCT-Vascular Access Her2 negative study, the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial.

Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.


Condition Intervention
Breast Cancer Cancer Device: venous access PORT or PICC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Simple, Prospective and Randomized Trial to Obtain Answers to Questions of Standard of Care: Vascular Access Strategies for (Neo) Adjuvant Breast Cancer Treatment Without Trastuzumab: A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Her2 Negative).

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Accrual rates [ Time Frame: One year ]
    Percentage of patients who receive (neo)adjuvant IV systemic therapy for Her 2 negative breast cancer compared to the number of participants who agree to randomization. The total number of new patients receiving (neo) adjuvant IV systemic cytotoxic therapy will be provided by the local chemotherapy pharmacy and Oncology Patient Information System records.

  • Patient compliance [ Time Frame: One year ]
    Percentage of participants who are randomized who accept randomization, and percentage of patients who cross-over to receive a central line while on study will be calculated using the chemotherapy treatment documentation in the designated hospital electronic patient record program


Secondary Outcome Measures:
  • Physician engagement [ Time Frame: One year ]
    Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.

  • Rates of thrombotic events [ Time Frame: One year ]
    2. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy.

  • Number of attempts at cannulation [ Time Frame: One year ]
    3. For those patients randomised to peripheral access information on the number of attempts at cannulation will be collected and site of cannulation. (ipsilateral to surgery vs contralateral to surgery)


Estimated Enrollment: 200
Study Start Date: April 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Venous access PORT or PICC
Participants will receive a central line placement either a PORT or a PICC prior to the initiation of chemotherapy.
Device: venous access PORT or PICC
Participants will receive a venous access prior to starting chemotherapy
No Intervention: No intervention
Participants will only receive a central line if required once chemotherapy has been initiated.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary breast cancer
  • Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting.
  • ≥19 years of age
  • Able to provide verbal consent

Exclusion Criteria:

• Contraindication to central line placement.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688998


Contacts
Contact: Mark Clemons, Dr. 613-737-7700 ext 70170 mclemons@toh.ca

Locations
Canada, Ontario
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Mark Clemons, Dr.    613-737-7700 ext 70170    mclemons@toh.on.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02688998     History of Changes
Other Study ID Numbers: 20160006-01H
First Submitted: February 18, 2016
First Posted: February 23, 2016
Last Update Posted: November 2, 2017
Last Verified: October 2017

Keywords provided by Ottawa Hospital Research Institute:
HER2 negative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents