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Trial Title:
Partial Breast Proton Therapy for Early Stage Breast Cancer
NCT ID:
NCT01310530
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Partial Breast
Proton Beam
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton Beam Radiotherapy
Description:
Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten
treatment sessions over two week as an outpatient.
Arm group label:
Partial Breast Proton Therapy
Summary:
The purpose of this is to determine the efficacy and toxicity of proton therapy when used
to deliver partial breast radiotherapy in patients with early stage breast cancer with
low or intermediate risk factors.
Detailed description:
Radiation therapy delivered to the whole breast is standard treatment following tumor
removal for patients with early stage breast cancer. In selected patients, delivering the
radiation treatment to only the part of the breast involved by the tumor may be a viable
alternative. This can decrease the amount of normal tissues exposed to irradiation,
potentially decrease side-effects and shorten the treatment time. Proton beam can
decrease the volume of normal tissues treated compared to standard forms of radiotherapy.
This study will recruit patients with early stage breast cancer following surgical
removal to undergo partial breast radiotherapy with proton beam and determine the
recurrence rates and side-effects of treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast carcinoma
- DCIS
- Age 40 years or higher
- Primary tumor 3 cm or less
- Lumpectomy with clip placement
- Axillary node sampling
- Negative margins
Exclusion Criteria:
- Distant metastasis
- Multicentric disease
- Prior radiation or chemotherapy
- Active collagen vascular disease
- Pregnant or lactating
- BRCA mutation
- Lymph nodes with more than microscopic tumor involvement
Gender:
Female
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
Address:
City:
Loma Linda
Zip:
92354
Country:
United States
Facility:
Name:
Loma Linda University Medical Center
Address:
City:
Loma Linda
Zip:
92354
Country:
United States
Start date:
May 4, 2011
Completion date:
May 2025
Lead sponsor:
Agency:
Loma Linda University
Agency class:
Other
Source:
Loma Linda University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01310530
