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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00907868
First received: May 22, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: partial breast irradiation
Radiation: whole breast irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 1950
Study Start Date: November 2008
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
Radiation: whole breast irradiation
Patients undergo 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).
Radiation: partial breast irradiation
Patients undergo radiation tumor bed boost
Radiation: whole breast irradiation
Patients undergo whole breast irradiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907868

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: David Azria, MD, PhD    33-4-6761-3132    David.Azria@valdorel.fnclcc.fr   
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: David Azria, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00907868     History of Changes
Other Study ID Numbers: CDR0000636007, INCA-BONBIS, RECF0911, VA-2008/25, ID-RCB-2008-A00494-51
Study First Received: May 22, 2009
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on August 21, 2014