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Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

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ClinicalTrials.gov Identifier: NCT02958774
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa Mitchell, University of Kansas Medical Center

Brief Summary:
The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Hypofractionated Radiation Therapy Not Applicable

Detailed Description:
Participants with stage II or stage III node-positive breast cancer, or T3N0 node-negative will receive hypofractionated radiation for 4 weeks. We hypothesize that patients receiving a shorter course of radiation will have reduced lymphedema. Lymphedema is diagnosed when the patient's arm circumference measures 10% or more as compared to pre-treatment (baseline) arm circumference measurement. Secondary endpoints will address the effectiveness, quality of life, and side effect profile of a shortened course of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Hypofractionated Radiation Therapy
Daily for 4 weeks
Radiation: Hypofractionated Radiation Therapy
Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily




Primary Outcome Measures :
  1. Lymphedema Rate [ Time Frame: One year post end of treatment (EOT) ]
    Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement.


Secondary Outcome Measures :
  1. Local Recurrence [ Time Frame: 12 months post-EOT ]
    Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes

  2. Cosmetic (Breast) Outcome [ Time Frame: 12 months post-EOT ]
    Measured using the Breast Q™ Assessment questionnaire

  3. Quality of Life [ Time Frame: After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT ]
    Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire

  4. Range of Motion (Upper Extremities) [ Time Frame: 14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT ]
    Percent reduction in referrals to physical therapy for impaired range of movement post-EOT



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky Performance Status 50% - 100%
  • Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include: T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer.
  • For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤ 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension
  • Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last.
  • Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.

Exclusion Criteria:

  • Diagnosis of inflammatory breast cancer
  • Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
  • Diagnosis of scleroderma
  • Diagnosis of lupus
  • Diagnosis of active dermatomyositis
  • Diagnosis of metastatic disease
  • Pregnant or nursing

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): NCT02958774


Contacts
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Contact: Melissa Mitchell, MD 9135885000 mmitchell2@kumc.edu
Contact: Mindi J TenNapel, PhD 9135885000 mtennapel@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Melissa Mitchell, MD    913-588-5000    mmitchell2@kumc.edu   
Contact: Mindi TenNapel, PhD    9135885000    mtennapel@kumc.edu   
Sponsors and Collaborators
Melissa Mitchell
Investigators
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Principal Investigator: Melissa Mitchell, MD University of Kansas Medical Center

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Responsible Party: Melissa Mitchell, Medical Doctor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02958774     History of Changes
Other Study ID Numbers: IIT-2017-MM-BRST-HypoFracRT
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases