MAC23 (ALLIANCE A221505)

 
 
Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction
Status: Open to Accrual
Activation Date: March 27, 2018
NCT Registration ID (from clinicaltrials.gov): NCT03414970

Summary

    Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction
    Complexity Level: 2

    Eligibility: This study will recruit women and men >=18 post mastectomy due to invasive breast cancer with planned chest wall reconstruction and radiation. Patients will be approached based on the following main criteria: no prior radiation therapy to the chest, neck or axilla, no prior history of ipsilateral breast cancer, no history of prior or concurrent contralateral invasive breast cancer, negative inked histologic margins from mastectomy pathology and Zubrod performance status of 0-1

    Objectives: To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Secondary objectives include: acute and late radiation complications, based on CTCAE 4.0 toxicity, local and local regional recurrence rate, photographic cosmesis 24 months after radiation, lymphedema at 24 months after radiation, patient satisfaction and well-being at 24 months after radiation (BreastQ,)compare reconstruction complication rates based on reconstruction method and timing of reconstruction, cost and healthcare utilization based on hypofractionation and reconstruction technique

    NCT Registration ID (from clinicaltrials.gov): NCT03414970
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 27, 2018

    Enrollments:

    Chair: (Canada) Dr. Iwa Kong, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9711 Ext. 63123, (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495



DSMC Reports

  • NA

 

Spring Meeting Report

Publications

  • Pending - Primary Publication
Lead Group Study Chair:
For clinical questions (e.g. patient eligibility
or treatment-related).
Dr. Matthew M. Poppe Phone: 801-581-8793
Fax: 801-582-3502
CCTG Study Coordinator: Dora Baczyk Phone: 613-533-6430
CCTG Clinical Trials Assistant: Amy Hawkins Phone: 613-533-6430
CCTG Ethics Research Associate: Centre Contact Phone: 613-533-6430

Consent

Case Report Forms


Patient Reported Outcomes

Memos

  • NA

News / Miscellaneous

  • NA

Manuals

  • Please refer to Section 6.2 of the protocol for Specimen Submissions.