Phyllodes Tumor Partial Breast Radiation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01089374
First received: March 17, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
Phyllodes Tumor
Radiation: Partial breast radiation after lumpectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of Partial Breast Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Local Recurrence [ Time Frame: every 6 months for 5 years after initial resection ] [ Designated as safety issue: No ]
    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:
  • Local recurrence after radiation [ Time Frame: every 6 months for 5 years after initial resection ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Partial breast radiation after lumpectomy
Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089374

Contacts
Contact: Richard J Barth, JR, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Richard J Barth, JR, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Richard J Barth, JR, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01089374     History of Changes
Other Study ID Numbers: DMS0929
Study First Received: March 17, 2010
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Phyllodes

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

ClinicalTrials.gov processed this record on July 22, 2014