search
Back to results

High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose Intracavitary Brachytherapy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Intracavitary brachytherapy, radiation therapy, Stage I breast cancer, Stage II breast cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion < or = to 3cm, treated with partial mastectomy 45 years of age or older Negative inked pathologic specimen > or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed prior to introducing radiation source Negative post-partial mastectomy or post re-excision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy Invasive ductal, medullary, papillary, colloid, or tubular histologies Time interval from final definitive breast surgical procedure to brachytherapy treatment is less than 8 weeks Exclusion Criteria: Distant metastases Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast malignancies such as sarcoma or lymphoma Proven multifocal, multicentric carcinoma with other clinically or radiologically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy Pregnant or lactating Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor Prior non-hormonal therapy for the present breast cancer, including radiation therapy and chemotherapy Collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, keloid, ataxia, telangiectasia, or dermatomyositis Co-existing medical condition in whom life expectancy is < 2 years Psychiatric or addictive disorders Paget's disease of the nipple Skin involvement regardless of size Breast unsatisfactory for brachytherapy Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation Extensive intraductal carcinoma Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in this study Diffuse suspicious microcalcifications

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
December 20, 2007
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00165581
Brief Title
High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
Official Title
A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
Due to continuing review
Study Start Date
December 2002 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to understand the side effects (skin reaction, infection and abscess formation) at the site of radiation treatment, which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer.
Detailed Description
Radiation treatment will be delivered in an outpatient setting, twice a day in 5 consecutive treatment days. There will be a minimum 6-hour interval between the two daily treatments. The applicator is a simple tube with an inflatable balloon at one end, a channel in the middle of the tube for treatment, and two adapters at the other end. Following surgical removal of the breast cancer, the radiation oncologist with the assistance of the surgeon or radiologist will place the applicator in the surgical cavity. A small radioactive source, iridium-192, will be inserted into the applicator by a special machine and after the final treatment, the applicator will be removed. The following procedures will be done while the patient is on radiation therapy: post-partial mastectomy mammogram of micro-calcifications to confirm complete removal; CT scans for radiation treatment planning; monitoring of the skin for side effects; photographs of the breasts prior to the surgery, prior to placement of the applicator and at 60 days after radiation treatment to evaluate the cosmetic outcome of the treatment. Participation in this study will last approximately 2 months after completion of radiation treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Intracavitary brachytherapy, radiation therapy, Stage I breast cancer, Stage II breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
High Dose Intracavitary Brachytherapy
Primary Outcome Measure Information:
Title
To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion < or = to 3cm, treated with partial mastectomy 45 years of age or older Negative inked pathologic specimen > or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed prior to introducing radiation source Negative post-partial mastectomy or post re-excision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy Invasive ductal, medullary, papillary, colloid, or tubular histologies Time interval from final definitive breast surgical procedure to brachytherapy treatment is less than 8 weeks Exclusion Criteria: Distant metastases Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast malignancies such as sarcoma or lymphoma Proven multifocal, multicentric carcinoma with other clinically or radiologically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy Pregnant or lactating Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor Prior non-hormonal therapy for the present breast cancer, including radiation therapy and chemotherapy Collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, keloid, ataxia, telangiectasia, or dermatomyositis Co-existing medical condition in whom life expectancy is < 2 years Psychiatric or addictive disorders Paget's disease of the nipple Skin involvement regardless of size Breast unsatisfactory for brachytherapy Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation Extensive intraductal carcinoma Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in this study Diffuse suspicious microcalcifications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip M. Devlin, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma

We'll reach out to this number within 24 hrs