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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

adjuvant therapy

conventional surgery

intraoperative radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, ductal breast carcinoma in situ, breast cancer in situ

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00054301

First Posted

February 5, 2003

Last Updated

July 23, 2020

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00054301

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, ductal breast carcinoma in situ, breast cancer in situ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Description

Patients undergo excisional biopsy or surgery.

Intervention Type

Radiation

Intervention Name(s)

intraoperative radiation therapy

Intervention Description

Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity.

Primary Outcome Measure Information:

Title

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.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shelli Hanks, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial