Status:
COMPLETED
Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold markers in the area where the tumor was removed may help doctors better direct radiation therapy and help reduce ...
Detailed Description
OBJECTIVES: Primary * To determine if the delivery of external-beam accelerated partial breast irradiation (APBI) based on gold fiducial markers is more accurate when compared to the delivery of rad...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Inclusion criteria:
- Histologically confirmed ductal carcinoma in situ or invasive carcinoma of the breast (including ductal, medullary, papillary, colloid \[mucinous\], or tubular histologies) meeting all of the following criteria:
- AJCC stage 0, I, or II (Tis, T1N0, or T2N0) disease with a lesion ≤ 3 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
- Unifocal breast cancer (i.e., single focus that can be encompassed by one lumpectomy)
- Underwent or plan to undergo lumpectomy with placement of gold fiducial markers (markers placed concurrently with the surgery or on a later date)
- Patients who has underwent lumpectomy must meet all of the following criteria:
- Must be enrolled between 14-60 days from date of last surgery, and radiation must start within 15-80 days of date of last surgery
- Four to six gold fiducial markers placed in the tumor bed, delineating the margins of the lumpectomy cavity
- Negative, inked histologic margins of lumpectomy (\> 1 mm) or re-excision specimen to be confirmed prior to radiation
- Margins are unacceptable if there is invasive or non-invasive tumor within 1 mm of the inked margin
- Negative post-excision mammography if malignancy-associated microcalcifications were initially present
- Hormone receptor status not specified
- Exclusion criteria:
- Evidence of suspicious microcalcifications in the breast prior to the start of radiation
- One or more positive axillary nodes or positive sentinel biopsy
- Distant metastases
- Invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma
- Proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
- Paget's disease of the nipple
- Skin involvement, regardless of tumor size
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-1
- Life expectancy ≥ 2 years
- Not pregnant or nursing
- No prior treated breast carcinoma within the past 5 years
- No collagen vascular diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No co-existing medical conditions
- No patients with medical conditions that would preclude compliance with the trial, as determined by the investigator
- No other malignancy, except non-melanomatous skin cancer, within the past 5 years
- Disease-free interval from any prior carcinoma must be continuous
- No breast technically unsuitable for radiotherapy
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent tamoxifen citrate, anastrozole, or other hormonal therapy allowed
- Future chemotherapy allowed provided it is administered after the APBI and begins no earlier than 2 weeks after completion of radiotherapy
- No tylectomies so extensive that the cosmetic result is low or poor prior to radiation
- No prior radiation to the ipsilateral breast
- No prior non-hormonal therapy or radiotherapy for this disease
- No chemotherapy in the past 2 weeks
- No concurrent chemotherapy, immunotherapy, or experimental medications
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00749437
Start Date
October 1 2008
End Date
July 1 2010
Last Update
June 14 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903