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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Shelli Hanks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

ICC4102

NCT ID:

NCT00054301

Start Date:

November 2002

Completion Date:

October 2004

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065