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

December 30, 2018 updated by: Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Radiotherapy
Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Radiation: Adjuvant Radiotherapy
Adjuvant radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Recurrence Rate
Time Frame: 36 months after initial excision
Local recurrence rate of phyllodes tumors
36 months after initial excision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: Approximately 5 years
Survival will be tracked for 10 years after initial resection of first participant treated.
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Richard J. Barth, MD, Norris Cotton Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1998

Primary Completion (Actual)

November 17, 2008

Study Completion (Actual)

November 17, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

December 30, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9801 CDR0000066410
  • P30CA023108 (U.S. NIH Grant/Contract)
  • DMS-9801
  • DMS-12752
  • NCI-V98-1442

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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