- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215162
Phase II Study of Intra-Operative Electron Irradiation and External Beam Irradiation After Lumpectomy in Patients With T1N0M0 and T2N0M0 Breast Cancer
April 2, 2014 updated by: Mayo Clinic
The study is being done to determine the tolerance to single fraction intra-operative electron irradiation (IOERT) and external beam photon irradiation (EBRT) following lumpectomy for T1/T2N0M0 breast cancer.
IOERT is used in lieu of the 5-8 days of electron beam boost irradiation that is usually given after EBRT.
Data from two centers as well as preliminary data from a randomized trial in Europe suggest that IOERT boost is well tolerated and efficacious.
In our study, patients will undergo standard lumpectomy and sentinel lymph node sampling or axillary dissection.
After the lumpectomy, IOERT of 10 Gy will be delivered in a single fraction to the tumor bed by a mobile electron machine in the operating room.
EBRT to the whole breast will be administered once the surgical wound has healed adequately.
The primary objective is to determine the feasibility and acute patient tolerance to IOERT and EBRT after lumpectomy.
Secondary objectives include assessment of local control and distant control of disease, as well as evaluation of long-term side effects and cosmetic outcome of the treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
-
Scottsdale, Arizona, United States
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Eligibility:
- Histologically proven primary invasive breast carcinoma.
- Tumor pathologically determined <= 5cm in diameter.
- Single, discrete, well-defined primary tumor.
- Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
- Pathologically negative surgical margins.
- Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
- ECOG performance status 0-2.
Contraindications:
- Multicentric disease and/or diffuse malignant appearing microcalcifications.
- Evidence of metastatic breast cancer.
- Axillary lymph node involvement.
- Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
- Prior irradiation to the ara of planned radiation field.
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm study
Patients with stage T1/T2No breast cancer receiving breast conserving treatment
|
IOERT is given to the tumor bed.
Applicator selection should allow treatment of the tumor bed plus 1-2 cm margin.
The surgical incision may need to be enlarged slightly to allow the placement of the appropriate applicator.
The use of more than 1 treatment field is discouraged.
In order to encompass the entire tumor bed in 1 treatment field, it may be necessary to suture the mammary parenchyma loosely so that the lateral margins of the tumor bed are brought into apposition.
Electron energy used for the treatment.
If the tumor bed can be flattened and encompassed by an applicator, 6 MeV electron is recommended.
Use of bolus material may be considered to increase the surface dose.
If the mammary parenchyma has been brought into apposition by sutures, a higher electron energy may be necessary to allow adequate dose coverage to a depth of 1.0-2.0
cm into the tumor bed.
The dose of IOERT is 1000 cGy, prescribed to the 90% isodose line.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the feasibility and acute patient tolerance of IOERT and EBRT after lumpectomy for patients with stage T1/T2N0M0 breast cancer.
Time Frame: weekly evaluation during 5 weeks of radiation
|
To determine the acute skin reaction, breast edema, pnemonitis, cardiac side effects during radiation using RTOG acute toxicity scale
|
weekly evaluation during 5 weeks of radiation
|
Determine the local tumor control and distant tumor control rates for patients with stage T1/T2N0M0 breast cancer.
Time Frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
|
every 6 months follow-up for 5 years, then yearly to end in 04/2013
|
|
Determine long-term side effects and cosmetic outcome of IOERT to tumor bed and EBRT after lumpectomy for patients with stage T1/T2N0Mo breast cancer.
Time Frame: every 6 months follow-up for 5 years, then yearly to end in 04/2013
|
To determine the late skin reaction, breast edema, pneumonitis, cardiac side effects during radiation using RTOG late toxicity scale
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every 6 months follow-up for 5 years, then yearly to end in 04/2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
August 7, 2009
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Estimate)
April 3, 2014
Last Update Submitted That Met QC Criteria
April 2, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1681-02 (Mayo Clinic IRB)
- MCS066 (Mayo Clinic Cancer Center)
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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