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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 11, 2009

Start Date ^ICMJE

January 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Local recurrence rate [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Local recurrence rate

Change History

Complete list of historical versions of study NCT00003404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival rate [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Survival rate

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

Official Title ^ICMJE

A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Radiation: radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003404

Responsible Party

Study ID Numbers ^ICMJE

CDR0000066410, DMS-9801, DMS-12752, NCI-V98-1442

Study Sponsor ^ICMJE

Norris Cotton Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Richard J. Barth, MD

Norris Cotton Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP