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Phyllodes Tumor Partial Breast Radiation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01089374
Recruitment Status : Recruiting
First Posted : March 18, 2010
Last Update Posted : July 30, 2018
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Brief Summary:

In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes tumors decreases rate of recurrence. None of the 46 participants developed a local recurrence.

Based on information we have learned from research studies, we recommend whole breast radiation therapy for women with malignant and borderline phyllodes tumors after they receive a lumpectomy.

New methods for delivering breast radiotherapy are being developed that allow radiation to be delivered solely to the site of the surgical resection. This is called partial breast radiation. The main advantage of partial breast radiation is that it simplifies treatment for the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6 weeks. The main concern is that partial breast radiation might miss other sites of breast cancer in the breast receiving the radiation.

Evidence is accumulating from research studies that partial breast radiation therapy after surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the breast results in rates of local recurrence that are comparable to those seen after whole breast radiation therapy.

In contrast to patients with invasive ductal cancers of the breast, it is very rare for patients to have phyllodes tumors that appear in more than one area of the breast. Review of research data determined that cancer recurrences seen in patients with phyllodes tumors that had undergone lumpectomies were almost always at the original tumor site. Therefore, partial breast radiation is likely to be as effective as whole breast radiation therapy after resection of malignant phyllodes tumors.

The purpose of the study is to determine what the chances are that a phyllodes tumor will recur in the breast when the breast is treated with partial breast radiation therapy after a lumpectomy.

Condition or disease Intervention/treatment Phase
Phyllodes Tumor Radiation: Partial breast radiation after lumpectomy Not Applicable

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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 Partial Breast Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors
Study Start Date : January 2010
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Partial breast radiation after lumpectomy
Radiation per NSABP B-39/R0413 protocol.
Radiation: Partial breast radiation after lumpectomy
Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.

Primary Outcome Measures :
  1. Local Recurrence [ Time Frame: every 6 months for 5 years after initial resection ]
    the primary objective is to determine the local recurrence rate for patients with borderline or malignant phyllodes tumors treated with breast conserving resection with negative margins and adjuvant partial breast radiation therapy.

Secondary Outcome Measures :
  1. Local recurrence after radiation [ Time Frame: every 6 months for 5 years after initial resection ]
    The secondary objective is to compare the local recurrence rate observed after partial breast radiation therapy with that observed in historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic proof of phyllodes tumor of borderline or malignant grade, as first defined by Pietruszka and modified by Azzopardi and adopted by the World Health Organization (1,2,17):

    • Borderline malignant: 5-9 mitoses/10 HPF, pushing or infiltrating margins, 2+ (moderate) stromal cellularity and atypia.
    • Malignant: 10 or more mitoses / 10 HPF, predominantly infiltrating margins, usually 3+ (severe) stromal cellularity and atypia but occasionally 2+.
  • The tumor has been excised with a breast-conserving resection and there is no tumor seen at any of the margins of the resection.
  • No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast. Patients with a local recurrence of a previously excised phyllodes tumor are eligible if the recurrence is in the area of the previous excision.
  • No history of irradiation of the ipsilateral breast.
  • No evidence of other areas worrisome for cancer on physical examination and mammography of the ipsilateral breast.
  • Age >18 years.
  • Informed consent.
  • Documentation that either:

    1. the patient's medical insurance company has certified that they will pay for the cost of radiation therapy treatments, or
    2. a letter from the patient indicating that they explicitly understand the costs of radiation therapy and that the sponsor (Principal Investigator) of this study will not be held responsible for these costs.

Exclusion Criteria:

  • Histologically positive margins.
  • Breast carcinoma or ductal carcinoma in situ in the ipsilateral breast.
  • A history of irradiation to the ipsilateral breast.
  • Pregnancy. A urine pregnancy test will be performed on each fertile premenopausal female prior to entry into the study. Patients with childbearing potential must employ effective contraception during the radiation therapy.
  • A radiation planning CT scan which demonstrates a target lumpectomy cavity that is not clearly delineated or a target lumpectomy cavity/whole breast reference volume > 30%.
  • Unacceptable radiation therapy quality assurance parameters, as defined in Section 5 of the protocol.

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 identifier (NCT number): NCT01089374

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Contact: Richard J Barth, JR, MD 800-639-6918

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Richard J Barth, JR, MD    800-639-6918   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
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Principal Investigator: Richard J Barth, JR, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Richard J. Barth,Jr., MD, Dartmouth-Hitchcock Medical Center Identifier: NCT01089374     History of Changes
Other Study ID Numbers: D0929
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Keywords provided by Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center:

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