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Official Title
Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
Phase
Phase 3
Sponsor
Proton Collaborative Group
Enrollment
276
Timeline
Mar 2024 → Feb 2041
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Patients 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)
- 2Histologically 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
- 3Documentation 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
- 4History and physical exam within 90 days prior to study registration
- 5Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- 6Negative pregnancy test for women of child-bearing potential
- 7Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy
- 8Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed
- 9Bilateral 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
- 1Presence 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)
- 2Residual gross disease detected by imaging or clinical exam with the exception of \<2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost
- 3Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
- 4Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
- 5Presence of double/dual port tissue expander
- 6Clinical or radiographic evidence of distant metastatic disease
- 7Pregnant or breast-feeding females
- 8Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
- 9History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
- 10Known BRCA 1 or BRCA 2 mutation
- 11Presence of an active skin rash
- 12Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
Locations
7 sites participating in this study
Emory Proton Therapy Center
Atlanta, Georgia 30308
Sunil Dutta, MD
Mayo Clinic
Scottsdale, Arizona 85259
Carlos Vargas, MD
California Protons Cancer Therapy Center
San Diego, California 92121
Iain MacEwan, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →