- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927912
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.
SECONDARY OBJECTIVES:
I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.
III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.
OUTLINE:
Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Montreal
-
Québec, Montreal, Canada, H2X0C1
- Active, not recruiting
- Centre Hospitalier de I'Universite de Montreal
-
-
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Active, not recruiting
- University of North Carolina
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Completed
- University Hospitals
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Sachin Jhawar, MD
- Phone Number: 614-688-7371
- Email: Sachin.Jhawar@osumc.edu
-
Principal Investigator:
- Sachin Jhawar, MD
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57105
- Recruiting
- Avera Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pathologically proven diagnosis of breast cancer
Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
- Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
- Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
- History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
- Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
- Absolute neutrophil count > 1800 cells/cubic mm
- Platelets >= 75,000 cells/cubic mm
- Hemoglobin >= 8 g/dL
- Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patients must provide study specific informed consent prior to study entry
Exclusion Criteria:
- Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
- Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
- Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
- Two or more cancers not resectable through a single lumpectomy incision
- Bilateral breast cancer
- Ductal breast carcinoma in situ (DCIS) only
- Non-epithelial breast malignancies such as sarcoma/lymphoma
- Male breast cancer
- Paget's disease of the nipple
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
- Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity.
Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo lumpectomy
Other Names:
Undergo IOERT boost
Other Names:
Undergo whole breast radiation therapy
Other Names:
Undergo oncoplastic reconstruction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
Time Frame: Up to 30 days after surgery and IOERT boost
|
If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue.
Summary statistics will be used to report all complications.
|
Up to 30 days after surgery and IOERT boost
|
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
Time Frame: At 1 year from the end of therapy
|
The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
|
At 1 year from the end of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported cosmesis using the BCTOS
Time Frame: Baseline up to 3 years
|
The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time.
The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.
|
Baseline up to 3 years
|
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
Time Frame: Up to 3 years after completion of radiation therapy
|
physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
|
Up to 3 years after completion of radiation therapy
|
Quality of life assessed by Breast Cancer Treatment Outcome Scale
Time Frame: Up to 3 years after completion of radiation therapy
|
determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
|
Up to 3 years after completion of radiation therapy
|
Rate of ipsilateral breast tumor recurrence
Time Frame: At 5 years
|
The exact binomial confidence interval for the rate will be calculated.
|
At 5 years
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-16106
- NCI-2016-01294 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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