Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer

NCT04088435 | Terminated

• 1 other identifier: 19-0448
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.

Conditions

Breast Cancer; Breast Cancer, Invasive Ductal; Invasive Mammary Carcinoma; Breast Cancer Stage I; Breast Cancer Stage IIA

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with greater than or equal to grade 2 acute radiation toxicities

  Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0

  within 6 months of radiotherapy

Secondary Outcomes (3)

• Percentage of patients with greater than or equal to grade 2 late radiation toxicities

  starting three months after radiation and continuing for 5 years

• Percentage of patients with good or excellent cosmetic outcome as assessed by the Harvard cosmesis scale

  starting immediately after radiation and continuing for 5 years

• Percentage of patients who are very satisfied or somewhat satisfied by their cosmetic outcome as determined by the Breast-Q patient satisfaction self assessment

  starting immediately after radiation and continuing for 5 years

Interventions

Intraoperative radiotherapy RADIATION

The IORT component of this treatment is being delivered as per standard clinical practice. 20 Gy in one fraction will be delivered at the time of lumpectomy.

Also known as: electronic brachytherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive breast cancer that are clinically node negative, with tumors 2.5 cm or smaller in size.

You may qualify if:

• T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery
• Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node
• Tumors 2.5 cm or less in size (clinical preoperative staging)
• Estrogen receptor positive tumors (≥10%)
• Her2 negative/not over-expressed
• Patients 50 years of age or greater

You may not qualify if:

• Prior malignancy not in remission
• Active collagen vascular disease requiring active cytotoxic or immunotherapy
• Psychiatric or mental condition which would preclude informed consent
• Prior thoracic radiation which overlaps with IORT field
• Pregnant patients
• Patients \<50 years
• Risk of positive sentinel lymph node \>20% based on nomogram estimates
• Known lymph node metastases (i.e. clinically node positive)
• Patients with invasive lobular carcinoma
• Patients with pure DCIS
• Known multifocal or multicentric tumor
• Patients requiring neoadjuvant chemotherapy
• Patients requiring or choosing mastectomy with or without reconstruction
• Technical contraindications to IORT dose delivery including skin to balloon distance \<7 mm
• Medical contraindication to IORT, radiation or breast conservation

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

James Graham Brown Cancer Center at the University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 10, 2019
• Primary Completion: June 5, 2022
• Study Completion: June 5, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)