Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast - Full Text View

Sponsor:	Norris Cotton Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003404

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.

PURPOSE: This phase II trial is studying how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.

Condition	Intervention	Phase
Breast Cancer	Procedure: adjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Local recurrence rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival rate [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 1998

Detailed Description:

OBJECTIVES:

Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
Determine the survival rate in patients treated with this regimen.

OUTLINE: Within 12 weeks after prior local excision or breast reexcision, patients undergo adjuvant radiotherapy 5 days a week for a total of 28 treatments.

Patients are followed every 6 months for 10 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 6-7 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:
- Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia
- Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia
Must have been excised with breast-conserving resection
- No positive margins
Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision
No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the ipsilateral breast

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003404

Locations

United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators

Norris Cotton Cancer Center

Investigators

Study Chair:

Richard J. Barth, MD

Norris Cotton Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. Epub 2009 May 8.

Study ID Numbers:	CDR0000066410, DMS-9801, DMS-12752, NCI-V98-1442
Study First Received:	November 1, 1999
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00003404 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
phyllodes tumor

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Breast Neoplasms
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Site
Phyllodes Tumor
Sarcoma
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009