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8110 Gatehouse Road, Falls Church, VA 22042

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 (RTOG-3510)

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General Information

Age Group

Adults

Status

Active

Protocol Number

NCT04361240

Background Information

This study is being conducted at many medical centers around the country to compare two type of standard care radiation therapy: Photon Therapy (pronouced “fotahn”) and Proton Therapy (pronouced “pro-tahn”) — to find out which type of radiation is best for treating participants with non-metastatic breast cancer who are receiving nodal radiation. This study is designed to help discover if one type of radiation is better, about the same, or worse in terms of side effects, cure rates, length of life or quality of life after radiation. The study will specifically explore overall health and quality of life, heart problems and other possible side effects of radiation therapy, and healthcare use for the two types of radiation.

What are the two types of radiation therapy being studied?

Both Photon Therapy and Proton Therapy are FDA-approved radiation treatments and are on the cutting-edge of cancer therapy. Photon Therapy and Proton Therapy deliver similar radiation doses to the chest wall or breast tissue and the immediate surrounding lymph node areas. Because there may be small amounts of radiation to parts of the heart during radiation treatment, both Photon Therapy and Proton Therapy may increase your chances of having heart problems in the future. Proton Therapy reduces the amount of heart exposed to radiation. So, it has the potential to reduce heart problems compared to Photon Therapy. Radiation therapy after surgery (either lumpectomy or mastectomy) improves breast cancer-specific and overall survival for women with non-metastatic breast cancer.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Inova Fairfax Hospital
3300 Gallows Rd.
Falls Church, VA 22042

Inova Fair Oaks Hospital
3600 Joseph Siewick Dr.
Fairfax, VA 22033

Inova Alexandria Hospital
4320 Seminary Rd.
Alexandria, VA 22304

Inova Loudoun Hospital
44045 Riverside Pkwy.
Leesburg, VA 20176

Eligibility Information

  • Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy/local excision with any type of axillary or internal mammary node chain surgery or sampling. In the locally recurrent setting, lymph node surgery may not be indicated and is not required.
  • Additional eligibility in protocol

Ineligibility Information

  • Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution
  • Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Additional exclusions in protocol

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT04361240