IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: IORT

• Registration Number: NCT03536897
• Lead Sponsor: Mount Carmel Health System

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-05-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2028-02-27
• Study Completion: 2028-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 168

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IORT	IORT	All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.

Primary Outcome Measures

Name	Time	Method
In-Breast Tumor Recurrence (IBTR)	5 years	Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years	Overall Survival
Late Toxicity	5 years	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
Disease Free Survival	5 yeras	Disease Free Survival
Acute Toxicity	3 months	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)

Trial Locations

Locations (1)

Mount Carmel West Hospital; 🇺🇸 Columbus, Ohio, United States