Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer - Full Text View

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 Procedure: intraoperative radiation therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

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

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

Study ID Numbers:	CDR0000270347, CWRU-ICC-4102
Study First Received:	February 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00054301
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
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
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on January 14, 2009