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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypofractionated Radiation Therapy

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated Radiation Therapy

Arm Description

Daily for 4 weeks

Outcomes

Primary Outcome Measures

Lymphedema Rate

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

Secondary Outcome Measures

Local Recurrence

Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes

Cosmetic (Breast) Outcome

Measured using the Breast Q™ Assessment questionnaire

Quality of Life

Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire

Range of Motion (Upper Extremities)

Percent reduction in referrals to physical therapy for impaired range of movement post-EOT

Full Information

NCT ID

NCT02958774

First Posted

September 30, 2016

Last Updated

April 14, 2021

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02958774

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 23, 2017 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

389 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionated Radiation Therapy

Arm Type

Experimental

Arm Description

Daily for 4 weeks

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated Radiation Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Lymphedema Rate

Description

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

Time Frame

One year post end of treatment (EOT)

Secondary Outcome Measure Information:

Title

Local Recurrence

Description

Defined as biopsy proven recurrence of breast cancer involving the chest wall, breast, axilla, internal mammary or supraclavicular nodes

Time Frame

12 months post-EOT

Title

Cosmetic (Breast) Outcome

Description

Measured using the Breast Q™ Assessment questionnaire

Time Frame

12 months post-EOT

Title

Quality of Life

Description

Measured using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4) questionnaire

Time Frame

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

Title

Range of Motion (Upper Extremities)

Description

Percent reduction in referrals to physical therapy for impaired range of movement post-EOT

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shane Stecklein, MD, PhD

Phone

9135885000

sstecklein@kumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mindi J TenNapel, PhD

Phone

9135885000

mtennapel@kumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shane Stecklein, MD, PhD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shane Stecklein, MD, PhD

Phone

913-588-5000

sstecklein@kumc.edu

First Name & Middle Initial & Last Name & Degree

Mindi TenNapel, PhD

Phone

9135885000

mtennapel@kumc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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