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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: May 18, 2017
Last verified: May 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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:


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 ]

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 ]

Estimated Enrollment: 150
Study Start Date: February 2004
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy
Two week course of proton radiotherapy to the breast.
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   (Adult, Senior)
Sexes 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
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: 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