Phase II Randomised Clinical Trial of Accelerated Partial Breast Irradiation (APBI) Comparing 3-Dimensional Conformal Radiation Therapy and Multi-Catheter Interstitial Brachytherapy.
- 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
- To assess acute radiation-induced toxicity in these patients as assessed by NCI CTCAE
- To assess long-term radiation-induced toxicity in these patients as assessed by
- 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
- 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
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
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of successfully delivered accelerated partial breast irradiation
Never established as trial terminated
Pierre Thirion, MD
Saint Luke's Hospital
Ireland: Health Information and Quality Authority