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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003404
Other study ID # D9801 CDR0000066410
Secondary ID P30CA023108DMS-9
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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