A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShanghai Proton and Heavy Ion Center
About this trial
The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:
1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery? 2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
Eligibility criteria
Qualifiers
Histologically confirmed invasive breast cancer.
Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
Disqualifiers
Presence of Ductal Carcinoma In Situ (DCIS).
Tumor staging: Patients presenting with T4, N0, or N3c disease.
History of prior radiotherapy to the ipsilateral chest or breast.
Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
Trial design
Treatments tested in this trial
- Proton radiotherapy
- Photon radiotherapy
Treatment groups
780 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov