Comparing the effects of proton beam and conventional radiation on breast cancer patients
The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
This study tests whether proton beam radiation is safer and more effective than regular radiation for people with stage II and III breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03270072 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the differential impact of proton beam irradiation compared to conventional photon radiation on organs-at-risk in patients with stage II and III breast cancer. It serves as a correlative study for participants enrolled in the RadCOMP trial, which is a randomized phase III study focusing on the effectiveness of these two radiation therapies. By analyzing patient outcomes and side effects, the study seeks to provide insights into the safety and efficacy of proton therapy versus traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with stage II or III breast cancer who are eligible for radiation therapy as part of the RadCOMP trial.
Not a fit: Patients who are not scheduled to receive radiation therapy or those with metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved radiation treatment strategies that minimize damage to healthy organs while effectively targeting breast cancer.
How similar studies have performed: Other studies comparing proton and photon radiation therapies have shown promising results, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341) * Ability to understand and the willingness to sign a study-specific written informed consent document Exclusion Criteria: * There are no exclusion criteria.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Jimenez, MD — Massachusetts General Hospital
- Study coordinator: Rachel Jimenez, MD
- Email: RBJIMENEZ@PARTNERS.org
- Phone: 617-726-7559
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.