Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorProton Collaborative Group
About this trial
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.
This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Eligibility criteria
Qualifiers
Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
Must be female.
Must be > = 50 years of age.
Must have a life expectancy of at least 5 years based on age and co-morbidities.
Disqualifiers
Previous history of ipsilateral invasive breast cancer or DCIS.
Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
Non-epithelial malignancies such as sarcoma or lymphoma.
Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.
Trial design
Treatments tested in this trial
- Proton Radiotherapy
Treatment groups
132 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov