A Prospective Cohort Study Comparing Proton and Photon Hypofractionated Radiotherapy for Left-sided Breast Cancer.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Histologically confirmed invasive breast cancer.

• Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left 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.

• No distant metastasis.

• Age range: 18-80 years.

• Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.

• Non-pregnant and non-lactating women.

• Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.

Locations
Other Locations
China
Shanghai Proton and Heavy Ion Center
RECRUITING
Shanghai
Contact Information
Primary
Ping Li, M.D.
ping.li@sphic.org.cn
021-38296666
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 780
Treatments
Experimental: Proton therapy
Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Active_comparator: photon therapy
Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov