Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Cancer Trials Ireland
OBJECTIVES: Primary * To compare the rate of successfully delivered accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy vs multi-catheter interstitial brachytherapy in women with stage I or II invasive ductal carcinoma of the breast. * To establish potential patient participation in ongoing phase III clinical trials (e.g., NSABP-B-39, GEC-ESTRO, RAPID, MPORT, and IRMA) that compare APBI to standard whole-breast irradiation. Secondary * To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE version 3.0. * To assess long-term radiation-induced toxicity in these patients as assessed by RTOG-EORTC scale. * To assess the incidence and type of adverse events in the breast of these patients. * To assess the incidence and type of procedure-related complications in these patients. * To determine local control and pattern of recurrence in these patients. * To determine disease-free survival (distant and recurrence-free survival) of these patients. * To determine overall survival of these patients. * To assess cosmesis in these patients as assessed by the Breast Cancer Treatment Outcome and RTOG scales. * To assess treatment-related symptoms in these patients as assessed by the Breast Cancer Treatment Outcome scale. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients with a lumpectomy cavity/whole breast ratio 25-30% are assigned to treatment in arm II. * Arm I: Patients undergo accelerated partial breast irradiation (APBI) using 3-dimensional conformal radiation therapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo APBI using multi-catheter interstitial brachytherapy twice daily over 5-10 days (total of 10 fractions) in the absence of disease progression or unacceptable toxicity. Patients complete quality-of-life questionnaires at baseline, on the last day of treatment, at 4 and 24 weeks after completion of treatment, and then annually for 3 years. After completion of study treatment, patients are followed periodically for at least 5 years.
Age
50–120
Sex
FEMALE
Healthy volunteers
Not accepted
