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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003404
• Other study ID #: D9801 CDR0000066410
• Secondary ID: P30CA023108DMS-9
• Status: Completed
• Phase: N/A
• Start date: January 1998
• Est. completion date: November 17, 2008

Study information

• Verified date: December 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

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.

METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 17, 2008
• Est. primary completion date: November 17, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

1. Histologically proven phyllodes tumors of the breast with borderline or malignant grade, defined as 1 of the following:

1. Borderline, defined as 5-9 mitoses/10 high power fields (HPF), pushing or infiltrating margins, 2+ atypia

2. Malignant, defined as 10 or more mitoses/10 HPF, predominantly infiltrating margins, usually 3+ atypia with occasional 2+ atypia

2. Must have been excised with breast-conserving resection and no positive margins

3. Local recurrence of a previously excised phyllodes tumor allowed if the recurrence is in the area of the prior excision

4. No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast

5. Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

1. Age: 18 and over

2. Sex: Female

3. Menopausal status: Not specified

4. Performance status: Not specified

5. Life expectancy: Not specified

6. Hematopoietic: Not specified

7. Hepatic: Not specified

8. Renal: Not specified

9. Other:

1. Not pregnant

2. Negative pregnancy test

3. Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

1. Biologic therapy: Not specified

2. Chemotherapy: Not specified

3. Endocrine therapy: Not specified

4. Radiotherapy: No prior radiotherapy to the ipsilateral breast

5. Surgery: See Disease Characteristics

Related Conditions & MeSH terms

• Breast Cancer
• Phyllodes Tumor

Intervention

Radiation:
• Adjuvant Radiotherapy
Adjuvant radiation therapy

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence Rate	Local recurrence rate of phyllodes tumors	36 months after initial excision
Secondary	Survival Rate	Survival will be tracked for 10 years after initial resection of first participant treated.	Approximately 5 years