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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local recurrence rate

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Richard J. Barth, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066410

NCT ID:

NCT00003404

Start Date:

January 1998

Completion Date:

December 2019

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • phyllodes tumor
  • Breast Neoplasms
  • Phyllodes Tumor

Name

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002