breast-conserving surgery and whole-breast radiation therapy with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ (bonbis)

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving radiation therapy after surgery may kill any tumor cells that remain after surgery. it is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ. purpose: this randomized phase iii trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

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.

Eligibility 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)

Keywords: ductal breast carcinoma in situ