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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 : Completed
First Posted : January 27, 2003
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Adjuvant Radiotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 46 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
Actual Study Start Date : January 1998
Actual Primary Completion Date : November 17, 2008
Actual Study Completion Date : November 17, 2008


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




Primary Outcome Measures :
  1. Local Recurrence Rate [ Time Frame: 36 months after initial excision ]
    Local recurrence rate of phyllodes tumors


Secondary Outcome Measures :
  1. Survival Rate [ Time Frame: Approximately 5 years ]
    Survival will be tracked for 10 years after initial resection of first participant treated.



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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:

  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

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: Richard J. Barth,Jr., Chief, Section of General Surgery, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00003404     History of Changes
Other Study ID Numbers: D9801 CDR0000066410
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9801
DMS-12752
NCI-V98-1442
First Posted: January 27, 2003    Key Record Dates
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Richard J. Barth,Jr., 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