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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)

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.
 
ClinicalTrials.gov Identifier: NCT00907868
Recruitment Status : Active, not recruiting
First Posted : May 25, 2009
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information
First Submitted Date  ICMJE May 22, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2017)
Time to recurrence [ Time Frame: up to 15 years of follow up ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
Time to recurrence
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Radiation: partial breast irradiation
    Patients undergo radiation tumor bed boost
  • Radiation: whole breast irradiation
    Patients undergo whole breast irradiation
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
1950
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2029
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907868
Other Study ID Numbers  ICMJE CDR0000636007
INCA-BONBIS
RECF0911
VA-2008/25
ID-RCB-2008-A00494-51
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Azria, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date May 2020

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