NCT00165581

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2002

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

December 20, 2007

Conditions

Breast Cancer

Keywords

Intracavitary brachytherapyradiation therapyStage I breast cancerStage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

High Dose Intracavitary BrachytherapyDEVICE

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion \< or = to 3cm, treated with partial mastectomy
  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Phillip M. Devlin, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

December 1, 2002

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(2)