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Node Negative, Invasive Breast Cancer Single Fraction IOERT

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ClinicalTrials.gov Identifier: NCT02370797
Recruitment Status : Active, not recruiting
First Posted : February 25, 2015
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Brief Summary:
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Single Fraction IOeRT Not Applicable

Detailed Description:

See points VIII inclusion/exclusion criteria

Operation:

  • Lumpectomy, steninal node biopsy
  • IOeRT

After Surgery:

  • Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
  • Chemotherapy (if indicated)
  • Hormone therapy (if indicated)

Follow-Up

  • Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
  • Assessements of acute toxicity according to CTC-toxicity scoring system
  • Assessments of late toxicity according to LENT-SOMA scoring systems
  • Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
Study Start Date : February 2015
Estimated Primary Completion Date : February 2029
Estimated Study Completion Date : May 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single Fraction IOeRT
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
Radiation: Single Fraction IOeRT
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
Other Name: Intra-Operative electron radiation therapy




Primary Outcome Measures :
  1. Proportion of patients who are free of breast cancer. [ Time Frame: 10 years ]
    Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.


Secondary Outcome Measures :
  1. Local recurrance rate with acute toxicity and cosmetic evaluations [ Time Frame: 10 years ]

    AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up.

    Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
  • Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
  • Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months.
  • BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
  • Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
  • Grade 1, 2 acceptable
  • Associated LCIS is allowed
  • Estrogen receptor (ER) status of positive
  • Negative margins at ink on gross pathologic examination
  • Patient is node-negative, defined as N0 (i-) or N0 (i+)
  • Patient must be deemed functionally and mentally competent to understand and sign the informed consent

Exclusion Criteria:

  • Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
  • Immuno-compromised status
  • Pregnancy
  • Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
  • Breast cancer that involves the skin or chest wall, locally advanced breast cancer
  • Pure DCIS, all grades
  • Invasive lobular carcinoma
  • Evidence of lymphovascular invasion (LVI)
  • Invasive carcinoma with extensive intraductal component (EIC)
  • Neoadjuvant chemotherapy indicated
  • Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
  • Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
  • Estrogen receptor negative
  • Her2 positive
  • Grade 3

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): NCT02370797


Locations
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United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Juliann Reiland, MD Avera Cancer Insitute

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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02370797     History of Changes
Other Study ID Numbers: ACI-1450-IOERTSFX
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: June 2019

Keywords provided by Avera McKennan Hospital & University Health Center:
IOERT
Radiation
Single fraction
Lumpectomy
Radiation therapy
Avera

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases