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COMPRO

  • Status
    Accepting Candidates
  • Age
    19 Years - N/A
  • Sexes
    Female
  • Healthy Volunteers
    No
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Objective

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.

Description

This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.

Details

Full study title Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
Protocol number OCR45349
ClinicalTrials.gov ID NCT05856773
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN)

  • Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended

  • Documentation of negative metastatic workup by whole body Positron Emission Tomography * Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan

  • History and physical exam within 90 days prior to study registration

  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

  • Negative pregnancy test for women of child-bearing potential

  • Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy

  • Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed

  • Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such

Exclusion Criteria:

  • Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease)

  • Residual gross disease detected by imaging or clinical exam with the exception of

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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