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Intraoperative Radiation Therapy (IORT) in DCIS

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ClinicalTrials.gov Identifier: NCT03216421
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eileen Connolly, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Ductal Carcinoma in Situ Other: Quality of Life Questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Low/Intermediate Grade DCIS
Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.
Other: Quality of Life Questionnaires
Quality of Life questionnaires will be completed by each subject.

High Grade DCIS
Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.
Other: Quality of Life Questionnaires
Quality of Life questionnaires will be completed by each subject.




Primary Outcome Measures :
  1. Rate of local recurrence [ Time Frame: 5 years ]
    Defined by ipsilateral breast tumor recurrence


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
    Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT

  2. Overall survival [ Time Frame: 5 years ]
    Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.

  3. Acute Toxicities associated with IORT [ Time Frame: 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.

  4. Longterm radiation toxicity [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed DCIS of the breast
  • Clinical ≤ 2.0 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 performed within last 6 months
  • Appropriate renal, liver, and hematologic lab values
  • Women of child-bearing potential must have a negative pregnancy test within 1 week of IORT treatment
  • 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216421


Contacts
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Contact: Eileen Connolly, MD 212-305-5050 epc2116@cumc.columbia.edu
Contact: Mariamne Reyna, BS 646-317-4244 mo2213@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Eileen Connolly, MD    212-305-5050    epc2116@cumc.columbia.edu   
Contact: Mariamne Reyna    646-317-4244    mo2213@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Eileen Connolly, MD Assistant Professor of Radiation Oncology

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Responsible Party: Eileen Connolly, Assistant Professor, Columbia University
ClinicalTrials.gov Identifier: NCT03216421     History of Changes
Other Study ID Numbers: AAAQ7853
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eileen Connolly, Columbia University:
DCIS
Intraoperative Radiation (IORT)
Lumpectomy
Breast Conserving Surgery

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ