Intraoperative Radiation Therapy in Early Stage Breast Cancer
NCT ID: NCT02266602
Last Updated: 2019-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2012-02-29
2018-07-31
Brief Summary
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Detailed Description
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* Local recurrence in early stage breast cancer patients treated with IORT.
* Toxicity associated with IORT.
* Long-term disease-specific and overall survival
* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
* Quality of life in patients treated with IORT.
* Health care costs associated with IORT.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Patients treated with intraoperative radiation therapy at the time of partial mastectomy.
Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Interventions
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Intraoperative Radiation Therapy
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
3. Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
Exclusion Criteria
2. Participation in an investigational drug or device study.
3. Previous ipsilateral radiation to the thorax or breast.
4. Multifocal breast cancer.
5. Pregnant patients.
6. Patient not competent to provide informed consent.
7. Neoadjuvant systemic therapy.
8. Lymphovascular invasion on biopsy pathology
45 Years
FEMALE
No
Sponsors
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Benaroya Research Institute
OTHER
Responsible Party
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Michelle Yao
MD
Principal Investigators
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Janie Grumley, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason Medical Center
Locations
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Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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11143
Identifier Type: -
Identifier Source: org_study_id
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