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

Breast Cancer Clinical Trial

Official title:

Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290654
• Other study ID #: 2002LS097
• Secondary ID: UMN-0211M35761
• Status: Terminated
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: December 3, 2017
• Start date: December 2002
• Est. completion date: March 2013

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Drug:
• Tamoxifen
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient

Procedure:
• Lumpectomy
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.

Radiation:
• brachytherapy
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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year after treatment
Primary	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.	5 years after treatment
Secondary	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.	within 6 months of treatment
Secondary	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.	more than 6 months after treatment, for up to 5 years
Secondary	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.	6 months after treatment
Secondary	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.	12 months after treatment
Secondary	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.	6 months after treatment
Secondary	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.	12 months after treatment