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

NCT02958774 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IIT-2017-MM-BRST-HypoFracRT
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Lymphedema Rate

  Defined as a 10% increase in arm circumference from pre-treatment (baseline) arm circumference measurement.

  One year post end of treatment (EOT)

Secondary Outcomes (4)

• Local Recurrence

  12 months post-EOT

• Cosmetic (Breast) Outcome

  12 months post-EOT

• Quality of Life

  After enrollment but prior to CT simulation; 14-90 days post-EOT; 12 months post-EOT

• Range of Motion (Upper Extremities)

  14-90 days post-EOT; 6 months post-EOT; 12 months post-EOT

Study Arms (1)

Hypofractionated Radiation Therapy

EXPERIMENTAL

Daily for 4 weeks

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy 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

Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shane Stecklein, MD, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: November 8, 2016
• Study Start: October 23, 2017
• Primary Completion: January 6, 2024
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

US (1)