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)

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: partial breast irradiation; Radiation: whole breast irradiation

• Registration Number: NCT00907868
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2011-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2004

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	whole breast irradiation	Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
Arm I	whole breast irradiation	Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
Arm II	partial breast irradiation	Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).

Primary Outcome Measures

Name	Time	Method
Time to recurrence	up to 15 years of follow up

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France