Proton Beam Radiation Therapy or Photon Beam Radiation Therapy in Treating Patients with Non-Metastatic Breast Cancer, A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT02603341
Trial Phases:	Phase III	Protocol IDs:	UPCC 19115 (primary) UPC 19115 NCI-2015-01950 823440
Eligibility:	21 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	University of Pennsylvania/Abramson Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02603341

Summary

This randomized phase III trial studies proton beam radiation therapy (proton therapy) compared to photon beam radiation therapy (photon therapy) in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy is an important treatment for breast cancer, however, radiation goes to other organs, such as heart, causing heart problems. Proton therapy is a type of radiation therapy that uses multiple beams of protons (tiny particles with a positive charge) to kill tumor cells. Photon therapy is also a type of radiation therapy which uses multiple x-ray beams to kill tumor cells. Proton therapy is theorized to deposit less radiation to healthy tissues beyond the cancer tumor. However, it is not yet known whether proton therapy is more effective than photon therapy in treating patients with non-metastatic breast cancer without causing heart damage.

Objectives

PRIMARY OBJECTIVES:
I. To assess the effectiveness of proton versus (vs.) photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).

SECONDARY OBJECTIVES:
I. To assess the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence, defined as the first reported breast cancer recurrence of any type (local-regional or distant or cancer-specific mortality).
II. To assess the effectiveness of proton vs. photon therapy in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (HRQOL) (anxiety, social roles, financial toxicity, general satisfaction) and adverse events.
III. To develop predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and MCE and HRQOL outcomes.
IV. To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon beam radiation therapy for 5 to 7 weeks with or without a tumor bed boost within 12 weeks of breast cancer surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo image-guided proton beam radiation therapy for 5 to 7 weeks with or without a tumor bed boost within 12 weeks of breast cancer surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 6, and 12 months and then every 6-12 months thereafter.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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