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

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02958774
Collaborator
(none)
389
Enrollment
1
Location
1
Arm
124.3
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: Hypofractionated Radiation Therapy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
389 participants
Allocation:
N/A
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 :
Oct 23, 2017
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Lymphedema Rate [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 [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 [12 months post-EOT]

    Measured using the Breast Q™ Assessment questionnaire

  3. Quality of Life [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

  • Principal Investigator: Shane Stecklein, MD, PhD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02958774
Other Study ID Numbers:
  • IIT-2017-MM-BRST-HypoFracRT
First Posted:
Nov 8, 2016
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Apr 19, 2021