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Brief Title: Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
Official Title: Optimizing Preventative Adjuvant Linac-Based Radiation: The OPAL Trial a Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
Study ID: NCT03077841
Brief Summary: This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Detailed Description: PRIMARY OBJECTIVE: I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen. SECONDARY OBJECTIVES: I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen. II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559. III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer. IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival. V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale. VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor. ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor. After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
Community Cancer Center East, Indianapolis, Indiana, United States
Covenant Medical Center Harrison, Saginaw, Michigan, United States
Summit Medical Group, Berkeley Heights, New Jersey, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States
Presbyterian Hospital, Albuquerque, New Mexico, United States
OhioHealth Mansfield Hospital, Mansfield, Ohio, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
MD Anderson League City, League City, Texas, United States
Saint Luke's Baptist Health System, San Antonio, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
Name: Benjamin D Smith
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR