Comparing two types of radiation therapy for breast cancer
The Safety and Efficacy of IMPT or IMRT for Breast Cancer: A Prospective Observational Study
This study is testing whether a new type of radiation therapy for breast cancer is safer and more effective than the standard treatment to help patients feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06826885 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the safety and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) in breast cancer patients requiring radiotherapy. Eligible participants will receive either preoperative, postoperative, or definitive radiotherapy based on their treatment needs and physician recommendations. The study will monitor patients for at least five years to assess radiation-induced toxicities, cancer recurrence, overall survival, and quality of life. The choice between IMPT and IMRT will be made collaboratively by the patient and their healthcare team, considering various factors such as patient preference and reimbursement policies.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed breast cancer who are indicated for radiotherapy.
Not a fit: Patients who are pregnant, lactating, or have severe comorbidities that interfere with treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options with reduced side effects for breast cancer patients undergoing radiotherapy.
How similar studies have performed: Other studies have shown promising results with similar radiation therapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. Exclusion Criteria * Pregnant or lactating women. * Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation. * Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity. * Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Gang Cai, MD — Ruijin Hospital
- Study coordinator: Gang Cai, MD
- Email: cg11855@rjh.com.cn
- Phone: +86-021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.