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Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: February 5, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054301
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer


Condition Intervention Phase
Breast Cancer
 Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: intraoperative radiation therapy
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy Surgery
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
Detailed Description:

OBJECTIVES:

  • Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
  • Determine the local recurrence rates in patients treated with this regimen.
  • Determine the cosmetic outcome in patients treated with this regimen.

OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks.

Patients are followed at 1 month and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast

    • Primary tumor classified as T1, T2, or T3
  • Candidate for breast-conserving surgery
  • Must have undergone lumpectomy with negative margins or minimal margin involvement
  • Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
  • No evidence of metastatic disease

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Adult

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 3,500/mm^3
  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant

  • No other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

    • Prior contralateral breast cancer allowed if curatively treated more than 5 years previously
  • No severe psychiatric or medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the involved breast

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054301

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Ireland Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Shelli Hanks, MD Ireland Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000270347, CWRU-ICC-4102
Study First Received: February 5, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00054301     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
ductal breast carcinoma in situ
breast cancer in situ

Study placed in the following topic categories:
Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Adjuvants, Immunologic
Breast Neoplasms
Carcinoma, Ductal, Breast
 Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
 Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009



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