Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
This study has been terminated.
(Unable to recruit further patients.)
Sponsor:
Masonic Cancer Center, University of Minnesota
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00290654
First received: February 9, 2006
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Tamoxifen Procedure: Lumpectomy Radiation: brachytherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial |
Resource links provided by NLM:
Further study details as provided by Masonic Cancer Center, University of Minnesota:
Primary Outcome Measures:
- Ipsilateral breast tumor recurrence rate [ Time Frame: Month 6 and Yearly thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complication rates [ Time Frame: Week 3, Month 6, Yearly ] [ Designated as safety issue: Yes ]
- Cosmetic outcome [ Time Frame: Month 6, Yearly ] [ Designated as safety issue: No ]
| Enrollment: | 46 |
| Study Start Date: | December 2002 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lumpectomy with Brachytherapy
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.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290654
Locations
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
| Principal Investigator: | Todd M. Tuttle, MD | Masonic Cancer Center, University of Minnesota |
More Information
Additional Information:
No publications provided
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00290654 History of Changes |
| Other Study ID Numbers: | 2002LS097, UMN-0211M35761 |
| Study First Received: | February 9, 2006 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Masonic Cancer Center, University of Minnesota:
|
ductal breast carcinoma in situ breast cancer in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma |
Neoplasms, Ductal, Lobular, and Medullary Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on March 06, 2013
