The RadComp Study

Patient centered. Patient informed. Patient powered.

RadComp, short for Radiotherapy Comparative Effectiveness, compares two types of standard care radiation therapy for locally advanced breast cancer-- Photon Therapy (pronounced “fo-tahn”) and Proton Therapy (pronounced “pro-tahn”).

What We Hope to Learn

The effectiveness of proton vs. photon therapy in reducing major cardiovascular events and how treatment affects patient’s quality of life, such as financial burden, fatigue, and anxiety.

These objectives were chosen as study priorities by breast cancer patients themselves.

Eligibility

You may be eligible for this study if you

• Are 21 years or older
• Have been diagnosed with non-metastatic breast cancer
• Will be having radiation therapy

Participation Snapshot

If you decide to take part in this study this is what your participation will look like:

• Your doctor and research staff will discuss details of the study with you during consultation.
• If you are eligible and wish to participate, you will sign an informed consent document, which ensures you understand the study and your rights as a participant.
• You will then be randomly assigned to 1 of 2 treatment groups:

Group 1: Receives PHoton Therapy once a day, 5 days a week, for 5 to 7 weeks

Group 2: Receives PRoton Therapy once a day, 5 days a week, for 5 to 7 weeks

Randomization is a technique to improve the quality and fairness of studies. You have a 50/50 chance of getting into either treatment group -- like a coin flip. Assigning you to a group helps makes sure that each group has a similar mix of patients and is only done when doctors are not sure whether one treatment is better than the other. Both you and your doctor will be told which treatment you will get following your signed consent.

• Then you will begin radiation treatment and attend regular follow-up visits according to standard medical practice.
• You will complete health questionnaires at various time points: when you sign consent, 1 month follow-up, 6 month follow-up, and once yearly after that. For your convenience, you have the option to fill these questionnaires out online or in-person during follow-up visits.
  Current RadComp participants: Click to complete your questionnaires

• Once you finish treatment, doctors will follow your health for the remainder of the study.

For more information on how to enroll, talk to your doctor or Contact us

For more general information, visit our FAQs or go on ClinicalTrials.gov and refer to this study by the name: “Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial” or by its ClinicalTrials.gov identifier: NCT02603341.

 

ACKNOWLEDGEMENTS

PCORI Acknowledgement: Research reported in this study website was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1403-12804).

PCORI Disclaimer:  The views, statements, and opinions presented in this study website are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.