Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer (NCT00749437) | Clinical Trial Compass
CompletedPhase 1
Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer
United States34 participantsStarted 2008-10
Plain-language 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 the risk of cancer recurrence.
PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works in treating women with early-stage breast cancer.
Who can participate
Age range45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
What they're measuring
1
Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers
Timeframe: During radiation therapy
Trial details
NCT IDNCT00749437
SponsorUniversity of Medicine and Dentistry of New Jersey