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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

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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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



- 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
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

- 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


- 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


- 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


- See Disease Characteristics

- No concurrent participation in another therapeutic trial (participation in
epidemiologic studies is allowed)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Safety Issue:


Principal Investigator

David Azria, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque



Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating