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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00723294 |
Purpose
RATIONALE: Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
PURPOSE: This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: cryosurgery Procedure: therapeutic conventional surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma |
| Estimated Enrollment: | 99 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
Patients complete the Brief Pain Inventory before and after cryoablation and after surgery.
After completion of study treatment, patients are followed within 14 days.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
No lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, ductal carcinoma in situ (DCIS) with microinvasion, or invasive breast carcinoma
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
Contacts and Locations| United States, California | |
| Providence Saint Joseph Medical Center - Burbank | Recruiting |
| Burbank, California, United States, 91505 | |
| Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente 818-847-3220 | |
| United States, Connecticut | |
| Bridgeport Hospital | Recruiting |
| Bridgeport, Connecticut, United States, 06610 | |
| Contact: Clinical Trials Office - Bridgeport Hospital 203-384-4869 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612-9497 | |
| Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
| University Community Hospital | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Charles E. Cox, MD, FACS 813-745-8480 | |
| United States, Illinois | |
| Northwest Community Hospital | Recruiting |
| Arlington Heights, Illinois, United States, 60005 | |
| Contact: Michael R. Kinney 847-618-6660 | |
| United States, Maryland | |
| DeCesaris Cancer Institute at Anne Arundel Medical Center | Recruiting |
| Annapolis, Maryland, United States, 21401 | |
| Contact: Lorraine Tafra, MD 443-481-5300 | |
| United States, Michigan | |
| Genesys Regional Medical Center | Recruiting |
| Grand Blanc, Michigan, United States, 48439 | |
| Contact: Linsey P. Gold 810-606-5000 | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| United States, New York | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| United States, Pennsylvania | |
| Lankenau Cancer Center at Lankenau Hospital | Recruiting |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Contact: Paul B. Gilman, MD 610-645-2000 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| Study Chair: | Rache M. Simmons, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | American College of Surgeons Oncology Group ( David M. Ota ) |
| Study ID Numbers: | CDR0000600976, ACOSOG-Z1072 |
| Study First Received: | July 25, 2008 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00723294 History of Changes |
| Health Authority: | Unspecified |
|
invasive ductal breast carcinoma male breast cancer stage I breast cancer stage II breast cancer |
|
Carcinoma, Ductal Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Breast Neoplasms |
Carcinoma, Ductal, Breast Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
