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NCT Number: NCT00003404

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Phyllodes Tumor Sarcoma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and 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

Treatment and study plan

Adjuvant radiotherapy

Radiation

Adjuvant radiation therapy

Primary outcomes

  1. Local Recurrence Rate

    Time frame: 36 months after initial excision

    Local recurrence rate of phyllodes tumors

Secondary outcomes

  1. Survival Rate

    Time frame: Approximately 5 years

    Survival will be tracked for 10 years after initial resection of first participant treated.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2008
Study completion
2008
First posted
Jan 27, 2003
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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