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Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer (NRR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00182728
First received: September 15, 2005
Last updated: June 14, 2017
Last verified: June 2017
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.


Condition Intervention
Breast Cancer Procedure: surgery Procedure: therapy Radiation: radiation therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician [ Time Frame: 1 year follow up visit ]

    Rates of good/excellent cosmesis was evaluated using the following criteria:

    Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.

    Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.


  • Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients [ Time Frame: 1 year follow up visit ]

    Rates of good/excellent cosmesis was evaluated using the following criteria:

    Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.

    Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.


  • Incidence of Grade 3/4 Toxicity [ Time Frame: 3 months ]

    Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline:

    Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event


  • Ipsilateral Breast Recurrence [ Time Frame: 5 years ]
    Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).


Secondary Outcome Measures:
  • Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT [ Time Frame: 3 months ]
  • Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT [ Time Frame: 3 months ]
  • Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT [ Time Frame: 3 months ]

Enrollment: 89
Actual Study Start Date: March 18, 2003
Estimated Study Completion Date: July 2, 2027
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative Radiation Arm
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
Procedure: surgery
conventional
Procedure: therapy
neoadjuvant
Radiation: radiation therapy
intraoperative radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast. Feasibility will be determined by the rate of good/excellent cosmesis, as measured by the Radiation Therapy Oncology Group (RTOG) cosmetic rating scale, in patients treated with this regimen compared with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517.
  • Determine the incidence of grade 3-4 toxicity of this regimen in these patients.
  • Determine the rate of ipsilateral breast recurrence, including recurrence within the tumor bed as compared to elsewhere in the breast, in patients treated with this regimen.

Secondary

  • Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen.

OUTLINE: This is a non-randomized study.

Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I, II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume. Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy (i.e., lumpectomy) of the tumor. Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy. Patients with > 2 tumor-involved surgical margins undergo mastectomy. Patients determined to have a tumor size > 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 to 3 years.

  Eligibility

Ages Eligible for Study:   48 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary invasive ductal carcinoma of the breast

    • Tumor size ≤ 3 cm
    • No extensive intraductal component
    • Tumor must not be attached to the skin, underlying muscle, or chest wall
  • Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist

    • Tumor amenable to segmental mastectomy (i.e., lumpectomy)
  • No bilateral breast cancer
  • No clinical or radiographic multifocal disease not amenable to single segmental mastectomy

    • Patients with > 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 48 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • 0-2

Life expectancy

  • At least 5 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • No collagen vascular disease
  • No medical condition that would preclude surgery
  • Other prior malignancy allowed provided the following criteria are met:

    • Patient has undergone potential curative therapy for all prior malignancies
    • There is no evidence of any prior malignancy within the past 5 years
    • Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the breast

Surgery

  • No breast implants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182728

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: David Olilla, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Publications:

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00182728     History of Changes
Other Study ID Numbers: LCCC 0218
Study First Received: September 15, 2005
Results First Received: March 20, 2017
Last Updated: June 14, 2017

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
invasive ductal breast carcinoma
stage I breast cancer
stage II breast cancer

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

ClinicalTrials.gov processed this record on July 24, 2017