A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS
- Estimate and compare local recurrence-free survival of women with ductal breast
carcinoma in situ (DCIS) treated with breast-conserving surgery followed by whole
breast irradiation with vs without a radiation tumor bed boost.
- Compare relapse-free survival between the two arms.
- Compare overall survival.
- Compare acute and late toxicities.
- Compare cosmetic results and quality of life.
- Identify patients at risk for late toxicities using a biological test.
- Store blood samples at the CEPH (French Center of the Human Polymorphism Center) for
OUTLINE: This is a multicenter study. All patients undergo breast-conserving surgery (after
a single intervention or second excision) with a margin ≥ 1 mm. A superficial or deep margin
is acceptable if the surgery has left the skin tissue or the fascia pectoral muscle,
respectively. Twelve weeks later, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5
- Arm II: Patients undergo WBI as in arm I. Patients also undergo a radiation tumor bed
boost once daily for 8 fractions (weekdays only) over 2 weeks.
Quality of life will be assessed.
After completion of study treatment, patients are followed up every 6 months for 5 years and
then annually for 10 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Time to recurrence
David Azria, MD, PhD
Centre Val d'Aurelle - Paul Lamarque