Hypofractionated Radiotherapy in Breast Cancer

NCT03167359 | Completed Results DMC

• 1 other identifier: IRB00047240
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT. The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Conditions

Cancer, Breast; Inflammation

Keywords

Psychiatry; Radiation Therapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)

  Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.

  Duration of Study (Up to 18 months)

• Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline

  Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.

  Duration of Study (Up to 18 months)

• Number of Participants With Grade 3 Brachial Plexopathy

  Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome

  Duration of Study (Up to 18 months)

Secondary Outcomes (17)

• Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)

  Baseline, end of Follow Up (Up to 18 months) (up to 18 months)

• Change in Tumor Necrosis Factor (TNF) - Alpha Levels

  Baseline, Post Intervention (Up to 18 Months)

• Change in Soluble TNF Receptor 2 (sTNFR2) Levels

  Baseline, Post Intervention (Up to 18 Months)

• Change in Interleukin (IL)-6 Levels

  Baseline, Post Intervention (Up to 18 Months)

• Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels

  Baseline, Post Intervention (Up to 18 Months)

Study Arms (1)

Participants with Stage 0-III breast cancer

EXPERIMENTAL

Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.

Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy

Interventions

Hypofractionated Simultaneous Integrated Boost Radiotherapy RADIATION

Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.

Participants with Stage 0-III breast cancer

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:
• Prior Chemotherapy for Breast Cancer
• Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)
• Non-Caucasian Race
• Less than or equal to 50 years of age
• Requiring regional nodal irradiation without evidence of N3 disease

You may not qualify if:

• Males will be excluded
• Women who are pregnant or nursing a child may not take part in this study

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Mylin Torres
• Organization: Emory University

matorre@emory.edu

404-778-3473

Study Officials

• Mylin Torres, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: December 1, 2010
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: May 7, 2021
• Results First Posted: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)