The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged ≥18 years old

• Karnofsky Performance Status (KPS) score ≥70

• Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.

• ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.

• Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.

• Ability to understand and willingness to participate in the research and sign the informed consent form.

Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Gang Cai, MD
cg11855@rjh.com.cn
+86-021-64370045
Backup
Lu Cao, PhD, MD
chenjiayi0188@aliyun.com
+86-021-64370045
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 500
Treatments
Arm1: Postoperative radiotherapy
Patients who indicated postoperative radiotherapy using IMRT or IMPT.
Arm2:Preoperative radiotherapy
Patients who indicated preoperative radiotherapy using IMRT or IMPT.
Arm3:Definitive radiotherapy
Patients who indicated definitive radiotherapy using IMRT or IMPT.
Related Therapeutic Areas
Sponsors
Collaborators: Sichuan Cancer Hospital and Research Institute, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Shandong Cancer Hospital and Institute, Tongji Hospital
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov