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| Sponsor: | Cancer Institute of New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00749437 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: cone-beam computed tomography Procedure: implanted fiducial-based imaging Procedure: therapeutic surgical procedure Radiation: 3-dimensional conformal accelerated partial breast irradiation Radiation: 3-dimensional conformal radiation therapy Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | Feasibility of 3-D Conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage, Node Negative Breast Cancer Patients Using Acculoc Fiducial Markers: A Phase I Trial |
| Estimated Enrollment: | 34 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo planned lumpectomy with gold fiducial marker placement (if procedure not already performed). Patients who meet the post lumpectomy criteria for continue treatment in this study proceed to accelerated partial breast irradiation (APBI). Between 15-80 days after surgery, patients undergo 3-dimensional APBI (may be intensity-modulated radiotherapy) using CT-guided planning (with gold fiducial markers placed at lumpectomy) once daily, 5 days a week, for 15 days.
Patients undergo fluoroscopy weekly to determine real-time movement of bony anatomy and fiducial markers and cone-beam CT weekly to determine any change in volume of seroma cavity.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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:
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:
Negative, inked histologic margins of lumpectomy (> 1 mm) or re-excision specimen to be confirmed prior to radiation
Exclusion criteria:
PATIENT CHARACTERISTICS:
No other malignancy, except non-melanomatous skin cancer, within the past 5 years
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Principal Investigator: | Bruce G. Haffty, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Bruce George Haffty ) |
| Study ID Numbers: | CDR0000613036, CINJ-040801, CINJ-0220080173 |
| Study First Received: | September 6, 2008 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00749437 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |