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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Hypofractionated Radiation Therapy

• Registration Number: NCT02958774
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Study Start: 2017-10-23
• Primary Completion: 2024-01-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 388

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated Radiation Therapy	Hypofractionated Radiation Therapy	Daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cosmetic (Breast) Outcome	12 months post-EOT	Measured using the Breast Q™ Assessment questionnaire
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
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
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States