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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) (BONBIS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907868
First Posted: May 25, 2009
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
May 22, 2009
May 25, 2009
August 21, 2017
November 2008
May 2011   (Final data collection date for primary outcome measure)
Time to recurrence [ Time Frame: up to 15 years of follow up ]
Time to recurrence
Complete list of historical versions of study NCT00907868 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Radiation: partial breast irradiation
    Patients undergo radiation tumor bed boost
  • Radiation: whole breast irradiation
    Patients undergo whole breast irradiation
  • Active Comparator: Arm I
    Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
    Intervention: Radiation: whole breast irradiation
  • Experimental: Arm II
    Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
    Interventions:
    • Radiation: partial breast irradiation
    • Radiation: whole breast irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1950
October 2029
May 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00907868
CDR0000636007
INCA-BONBIS
RECF0911
VA-2008/25
ID-RCB-2008-A00494-51
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Institut du Cancer de Montpellier - Val d'Aurelle
Institut du Cancer de Montpellier - Val d'Aurelle
Not Provided
Principal Investigator: David Azria, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
Institut du Cancer de Montpellier - Val d'Aurelle
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP