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Proton Therapy for Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Bush, Loma Linda University
ClinicalTrials.gov Identifier:
NCT00614172
First received: December 26, 2007
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.


Condition Intervention Phase
Early-Stage Breast Cancer
 Radiation: Proton radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Determine the survival and recurrence rates associated with partial breast proton therapy. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the toxicity and the cosmetic results with partial breast proton therapy. To determine the local tumor control and survival associated with partial breast proton therapy [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Proton radiation therapy
    Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
Detailed Description:

Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

  Eligibility

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

Inclusion Criteria:

  • Invasive ductal, medullary, papillary, colloid or tubular histologies
  • Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen.
  • No more then 3 positive nodes on axillary dissection or negative sentinel node.
  • Negative surgical margins (>2mm)

Exclusion Criteria:

  • Invasive lobular histology
  • Previous chemotherapy for breast cancer
  • Extensive intraductal component
  • Collagen vascular disease
  • Prior malignancy unless disease-free for 5 years
  • Patients who are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614172

Locations
United States, California
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: David A. Bush, MD Loma Linda University Department of Radiation Medicine
Study Chair: Jerry D. Slater, MD Loma Linda University Department of Radiation Medicine
  More Information

Publications:

Responsible Party: David Bush, Principal Inverstigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT00614172     History of Changes
Other Study ID Numbers: OSR# 53294
Study First Received: December 26, 2007
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Proton
Radiation
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013