search
Back to results

Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen
Lumpectomy
brachytherapy
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy Size: < 3 cm on mammogram Unicentric disease Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy Patient Age: ≥ 18 years, no upper limit Life expectancy > 5 years Exclusion Criteria: Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix Pregnant or breast feeding Multicentric disease Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumpectomy with Brachytherapy

Arm Description

Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.

Outcomes

Primary Outcome Measures

Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.

Secondary Outcome Measures

Percentage of Patients Who Experienced Complications
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Percentage of Patients Who Experienced Complications
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.

Full Information

First Posted
February 9, 2006
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT00290654
Brief Title
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
Official Title
Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit further patients.
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.
Detailed Description
OBJECTIVES: Primary Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation Therapy System. Secondary Determine the early and late complication rates and cosmetic outcome in these patients after treatment. OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins* (no ink on tumor) undergo placement of the MammoSite^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery. NOTE: *If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met. Beginning 2-5 days after placement of the MammoSite^®, patients undergo brachytherapy through the MammoSite^® twice daily for 5 days (a total of 10 fractions). After completion of study treatment, patients are followed periodically for ≥ 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
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
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumpectomy with Brachytherapy
Arm Type
Experimental
Arm Description
Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
Intervention Type
Procedure
Intervention Name(s)
Lumpectomy
Intervention Description
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Description
Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.
Primary Outcome Measure Information:
Title
Number of Patients With Ipsilateral Breast Tumor Recurrence
Description
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Time Frame
1 year after treatment
Title
Number of Patients With Ipsilateral Breast Tumor Recurrence
Description
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Time Frame
5 years after treatment
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Experienced Complications
Description
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Time Frame
within 6 months of treatment
Title
Percentage of Patients Who Experienced Complications
Description
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Time Frame
more than 6 months after treatment, for up to 5 years
Title
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Description
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Time Frame
6 months after treatment
Title
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Description
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Time Frame
12 months after treatment
Title
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Description
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Time Frame
6 months after treatment
Title
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Description
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Time Frame
12 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy Size: < 3 cm on mammogram Unicentric disease Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy Patient Age: ≥ 18 years, no upper limit Life expectancy > 5 years Exclusion Criteria: Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix Pregnant or breast feeding Multicentric disease Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M. Tuttle, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

We'll reach out to this number within 24 hrs