Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00527293
First received: September 7, 2007
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon [ Time Frame: 1 month after RT & Q3mos for one year ] [ Designated as safety issue: No ]
- Patient satisfaction with partial breast irradiation as measured by a questionnaire [ Time Frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr ] [ Designated as safety issue: No ]
- Wound healing and overall complication rate after partial breast irradiation [ Time Frame: 1 month after RT & Q3mos for one year ] [ Designated as safety issue: No ]
- Determination of which patients are best suited for each individual technique of partial breast irradiation [ Time Frame: Patients will be followed for a period of five years following completion of radiation. ] [ Designated as safety issue: No ]
- Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates [ Time Frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | October 2014 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MammoSite Brachytherapy
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
|
Procedure: adjuvant therapy
If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
Radiation: brachytherapy
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
|
|
Experimental: 3-dimensional conformal radiotherapy
3-dimensional conformal radiotherapy twice daily for 5-10 days.
|
Procedure: adjuvant therapy
If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
Radiation: 3-dimensional conformal radiation therapy
3-dimensional conformal radiotherapy twice daily for 5-10 days.
|
Detailed Description:
OBJECTIVES:
- To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
- To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
- To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
- To evaluate wound healing and overall complication rate after partial breast irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, including the following histologic subtypes:
- Invasive ductal carcinoma
- Medullary ductal carcinoma
- Papillary ductal carcinoma
- Colloid (mucinous) ductal carcinoma
- Tubular ductal carcinoma
The following histologic subtypes are not allowed:
- Invasive lobular carcinoma
- Extensive lobular carcinoma in situ
- Ductal carcinoma in situ (DCIS)
- Nonepithelial breast malignancies, such as lymphoma or sarcoma
- No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
- Lesion ≤ 3 cm
No more than 3 positive lymph nodes
- Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
- Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
Unifocal breast cancer
No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
- No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
- No skin involvement of disease
- No Paget's disease of the nipple
- No distant metastatic disease
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or lactating
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
- No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
- No other malignancy within the past 5 years, except non-melanomatous skin cancer
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the breast
- No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
- Concurrent hormonal therapy allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527293
Locations
| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Lake/University Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44060 | |
| UHHS Chagrin Highlands Medical Center | |
| Cleveland, Ohio, United States, 44122 | |
| UHHS Westlake Medical Center | |
| Cleveland, Ohio, United States, 44145 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | Janice Lyons, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00527293 History of Changes |
| Other Study ID Numbers: | CASE2104, P30CA043703, CASE2104 |
| Study First Received: | September 7, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage I breast cancer stage II breast cancer invasive ductal breast carcinoma medullary ductal breast carcinoma with lymphocytic infiltrate |
mucinous ductal breast carcinoma tubular ductal breast carcinoma papillary ductal breast carcinoma |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013