Intraoperative Radiation Therapy (IORT) in DCIS

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Ductal Carcinoma in Situ
• Interventions: Other: Quality of Life Questionnaires

• Registration Number: NCT03216421
• Lead Sponsor: Columbia University

Brief Summary

The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.

Detailed Description

With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Study Start: 2017-09-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2027-08-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 265

Inclusion Criteria

• Pathologically confirmed DCIS of the breast
• Clinical ≤ 3.0 cm unifocal lesion
• No clinical or pathological evidence of nodal involvement
• Operable DCIS, suitable for breast conserving surgery
• Plans to administer irradiation to the breast only
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
• Must have had a diagnostic mammogram or MRI performed within last 6 months
• Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines
• Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period.
• English or Spanish speaking
• Able to sign informed consent
• Amenable to regular follow-up (according to research policies) for at least 5 years.

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Exclusion Criteria

• Histologic or clinical evidence of invasive breast cancer
• Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
• Synchronous bilateral breast cancer at the time of diagnosis
• Pathologic or imaging evidence of lymph node involvement
• Any severe concomitant disease that may limit their life expectancy to less than 5 years.
• Prior history of breast cancer or in-field radiation in the ipsilateral breast.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breast feeding women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low/Intermediate Grade DCIS	Quality of Life Questionnaires	Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.
High Grade DCIS	Quality of Life Questionnaires	Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.

Primary Outcome Measures

Name	Time	Method
Rate of local recurrence	5 years	Defined by ipsilateral breast tumor recurrence

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.
Acute Toxicities associated with IORT	6 months	Quantify the frequency of acute toxicities that occur within 6 months of having BCS and IORT. Measured using physician and patient reported toxicity surveys.
Disease-free survival	5 years	Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT
Longterm radiation toxicity	5 years	Quantify the frequency of toxicities that occur at greater than 6 months after having BCS and IORT. Measured using using physician and patient reported toxicity surveys as well as photographic assessment of cosmetic outcome.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States