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

NCT00290654 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2002LS097UMN-0211M35761
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ; breast cancer in situ

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Percentage of Patients Who Experienced Complications

  within 6 months of treatment

• Percentage of Patients Who Experienced Complications

  more than 6 months after treatment, for up to 5 years

• Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent

  6 months after treatment

• Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent

  12 months after treatment

• Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent

  6 months after treatment

Study Arms (1)

Lumpectomy with Brachytherapy

EXPERIMENTAL

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; Procedure: Lumpectomy; Radiation: brachytherapy

Interventions

Tamoxifen DRUG

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

Lumpectomy with Brachytherapy

Lumpectomy PROCEDURE

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

Lumpectomy with Brachytherapy

brachytherapy RADIATION

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.

Lumpectomy with Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Interventions

Tamoxifen; Mastectomy, Segmental; Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Mastectomy; Surgical Procedures, Operative; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Todd Tuttle, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

tuttl005@umn.edu

612-625-2991

Study Officials

• Todd M. Tuttle, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: December 1, 2002
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 28, 2017
• Results First Posted: May 15, 2015

Record last verified: 2017-12

Locations

US (1)