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

Tracking Information

First Received Date ^ICMJE

February 5, 2003

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00054301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer

Official Title ^ICMJE

Intraoperative Radiation Therapy to the Tumor Bed for Boost Treatment After Lumpectomy Prior to Whole Breast Radiation in Breast Conservation Candidates

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: intraoperative radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00054301

Responsible Party

Study ID Numbers ^ICMJE

CDR0000270347, CWRU-ICC-4102

Study Sponsor ^ICMJE

Ireland Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Shelli Hanks, MD

Ireland Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP