NCT00614172

Proton Therapy for Early Stage Breast Cancer

Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Early-Stage Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-02-01
• Primary completion: 2020-05-12
• Completion: 2020-05-12
• First posted: 2008-02-13
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study