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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Mayo Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Eligibility:

  1. Histologically proven primary invasive breast carcinoma.
  2. Tumor pathologically determined <= 5cm in diameter.
  3. Single, discrete, well-defined primary tumor.
  4. Any micro-calcifications must be focal. A specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications.
  5. Pathologically negative surgical margins.
  6. Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling.
  7. ECOG performance status 0-2.

Contraindications:

  1. Multicentric disease and/or diffuse malignant appearing microcalcifications.
  2. Evidence of metastatic breast cancer.
  3. Axillary lymph node involvement.
  4. Pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy.
  5. Prior irradiation to the ara of planned radiation field.
  6. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm study
Patients with stage T1/T2No breast cancer receiving breast conserving treatment
Radiation: Intra-operative radiation to tumor bed
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings