IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Breast Cancer Clinical Trial

Official title:

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536897
• Other study ID #: 180212-1
• Status: Recruiting
• Start date: February 27, 2018
• Est. completion date: February 27, 2028

Study information

• Verified date: August 2023
• Source: Mount Carmel Health System
• Contact: Lynn Shaffer, PhD
• Phone: 614-234-3625
• Email: Lynn.Shaffer[@]mchs.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: February 27, 2028
• Est. primary completion date: February 27, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Female

• ECOG performance status 0-1

• Age 65 years or older

• cT1 or cT2 (=3.0 cm)

• Invasive ductal carcinoma histology

• Estrogen receptor positive (ER+)

• Grade 1 or Grade 2

• Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling

• Suitable for breast conserving surgery and radiation therapy

• Patient must be able to provide study-specific informed consent

Exclusion Criteria:

• Multi-centric cancer not amenable to single lumpectomy

• Prior ipsilateral whole breast radiation

• Known BRCA 1 or BRCA 2 mutation

• Status post neoadjuvant hormonal or chemotherapy

• Invasive lobular histology

• Pure ductal carcinoma in situ (DCIS)

• Grade 3

• Diffuse suspicious microcalcifications

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• IORT
Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Locations

Country	Name	City	State
United States	Mount Carmel West Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mount Carmel Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Breast Tumor Recurrence (IBTR)	Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.	5 years
Secondary	Late Toxicity	Degree of late radiation toxicity will be scored based upon RTOG/EORTC (Radiation Therapy Oncology Group/Eastern Oncology Radiation Therapy Consortium) late radiation morbidity scoring schema for subcutaneous tissue as well as cosmetic result.; The RTOG/EORTC late radiation morbidity scoring schema on subcutaneous tissue is as follows: GRADE 1: Slight induration (fibrosis) and loss of subcutaneous fat; GRADE 2: Moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; GRADE 3: Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement; GRADE 4: Necrosis	5 years
Secondary	Acute Toxicity	Acute radiation toxicity will be scored at the first follow-up visit after IORT (4-6 weeks after treatment).; Radiation dermatitis will be scored based upon CTCAE (Common Terminology Criteria for Adverse Events) v4.03 scale as follows: GRADE 1: Faint erythema or dry desquamation; GRADE 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema; GRADE 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; GRADE 4: Life threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated; Other acute toxicity will also be scored per the CTCAE v4.03 scale and will be rated on the relation to radiation therapy (definitely related, probably related, possibly related, unlikely related, unrelated)	3 months
Secondary	Disease Free Survival	Disease Free Survival	5 yeras
Secondary	Overall Survival	Overall Survival	5 years