RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Not Applicable

Suspended

• Conditions: Breast Cancer
• Interventions: Radiation: 5 Fraction Stereotactic Body Radiation Therapy

• Registration Number: NCT03643861
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Detailed Description

This study offers 5 fractions stereotactic body radiotherapy for early stage breast cancer after patient undergoes a lumpectomy. The study aims to determine the safety and feasibility of delivering only 5 doses of radiation treatment rather than the longer schedule of treatments that is currently considered standard of care for breast cancer patients. Patients will be followed for 36 months (2 years) with follow-up appointments at 6, 12, 18, 24, and 36 months.

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Study Start: 2019-08-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pathologically proven invasive mammary carcinoma, Invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) of the breast. Medullary, papillary, mucinous (colloid) and tubular histologies are allowed.
• Age>50.
• Maximum pathologic tumor size <2.0cm if invasive carcinoma or < 2.5cm if pure DCIS.
• Estrogen receptor (ER) positive (>10%).
• Must be eligible for breast conservation therapy and receive a lumpectomy with pathologic margins of at least 2mm.
• Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative.
• Zubrod Performance Status 0-2.

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Exclusion Criteria

• Multifocal or multicentric cancer.
• Reception of neoadjuvant chemotherapy.
• Pure invasive lobular histology.
• Inability to clearly delineate lumpectomy cavity on post lumpectomy planning scan.
• Measured maximum PTV of >124cc.
• Lumpectomy cavity within 5mm of body contour.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5 Fraction Breast Stereotactic Body Radiation Therapy	5 Fraction Stereotactic Body Radiation Therapy	This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.

Primary Outcome Measures

Name	Time	Method
Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0	0-2 years	To determine the safety of 5 fractions SBRT for patients with early stage breast cancer after a lumpectomy. Safety will be determined by CTCAE v4.0 and access toxicity, or lack of, experienced by patients enrolled in this study.

Secondary Outcome Measures

Name	Time	Method
Toxicity of breast SBRT using CTCAE v4.0	0-2 years	To define the acute (\<90 days) and late toxicity (\>90 days) up to two years after breast SBRT (CTCAE 4) attributable to therapy.
Cosmetic outcome baseline and post-SBRT	0-2 years	To determine patient and nurse assessed cosmetic outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. Patient will give a verbal satisfaction rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor of their cosmetic appearance post-SBRT. Nurse will also give their overall rating of 1-Excellent, 2-Good, 3-Fair, or 4-Poor based off of their examination of the cosmetic appearance post-SBRT.
Patient reported outcome baseline and post-SBRT	0-2 years	To determine patient reported outcome at baseline and 1, 6, 12, 18, 24, and 36 months post SBRT. The Quality of Life Breast Cancer Questionnaire (QLQ-BR45) is a 45-item questionnaire is composed of 45 questions with scale of 4 options where 1 represents "not at all" to 4 "very much". Scores on the QLQ-BR45 range from 45 to 180, with a lower score representing a higher quality of life.

Trial Locations

Locations (1)

University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center (HSROC); 🇺🇸 Birmingham, Alabama, United States