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

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ClinicalTrials.gov Identifier: NCT00003404
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : November 30, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
Study Start Date : January 1998
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Radiation Procedure: adjuvant therapy
Radiation: radiation therapy



Primary Outcome Measures :
  1. Local recurrence rate [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Richard J. Barth, MD Norris Cotton Cancer Center

Publications of Results:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00003404     History of Changes
Other Study ID Numbers: CDR0000066410
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9801
DMS-12752
NCI-V98-1442
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: October 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
recurrent breast cancer
phyllodes tumor

Additional relevant MeSH terms:
Phyllodes Tumor
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms