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
18 Years
N/A
Female
Breast Cancer
Trial Information
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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Tertiary
- Store blood samples at the CEPH (French Center of the Human Polymorphism Center) for
polymorphism analyses.
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
weeks.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ of the breast
- No invasive component
- No clinically palpable lymph node or presence of tumor cells in the sentinel
lymph node (if done)
- No local recurrence of a primary breast cancer
- No multicentric or multifocal tumors not suitable for conservative surgery R0
with a margin ≥ 1 mm
- Has undergone bilateral mammography within 6 months before randomization
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 5 years
- Not pregnant
- Available for long-term follow up
- No history of in situ carcinoma in the contralateral breast
- No history of another cancer except for basal cell carcinoma of the skin or carcinoma
in situ of the cervix
- No uncontrolled cardiac, renal, or pulmonary disease
- No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)
- No HIV positivity
- Affiliated with the social health system
- No psychological, familial, sociological, or geographical situations that preclude
compliance with study treatment and follow up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent participation in another therapeutic trial (participation in
epidemiologic studies is allowed)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to recurrence
Safety Issue:
No
Principal Investigator
David Azria, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Val d'Aurelle - Paul Lamarque
Authority:
Unspecified
Study ID:
CDR0000636007
NCT ID:
NCT00907868
Start Date:
November 2008
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
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