Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer

NCT00749437 | Completed Phase 1

• 4 other identifiers: 040801P30CA072720CINJ-040801CINJ-0220080173
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; ductal breast carcinoma in situ; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; papillary ductal breast carcinoma; tubular ductal breast carcinoma; mucinous ductal breast carcinoma; breast cancer in situ

Outcome Measures

Primary Outcomes (1)

• Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers

  During radiation therapy

Secondary Outcomes (1)

• Movement of the fiducial markers themselves and the change in volume of the seroma cavity during a 15-fraction course of accelerated radiotherapy compared with the pre-radiation volume

  During radiation therapy

Interventions

3-dimensional conformal accelerated partial breast irradiation RADIATION

Accelerated partial breast irradiation following lumpectomy with placement of Acculoc fiducial markers.

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

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

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; Carcinoma, Ductal

Study Officials

• Bruce G. Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2008
• First Posted: September 9, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (1)