Clinical trial NCT02958774: Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
Official title: Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 388
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Lymphedema Rate
timeFrame: One year post end of treatment (EOT)
Secondary outcomes:
measure: Local Recurrence
timeFrame: 12 months post-EOT
measure: Cosmetic (Breast) Outcome
timeFrame: 12 months post-EOT
measure: Quality of Life
timeFrame: After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT
measure: Range of Motion (Upper Extremities)
timeFrame: 14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Shane Stecklein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: