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

NCT ID: NCT02958774

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2029-03-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated Radiation Therapy

Daily for 4 weeks

Group Type: EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shane Stecklein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

IIT-2017-MM-BRST-HypoFracRT

Identifier Type: -

Identifier Source: org_study_id