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 - Full Text View

Sponsor:	Centre Val d'Aurelle - Paul Lamarque
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00907868

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

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
Arm I: Active Comparator Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).	Radiation: whole breast irradiation Patients undergo whole breast irradiation
Arm II: Experimental 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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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
ClinicalTrials.gov Identifier:	NCT00907868 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Carcinoma in Situ
Breast Neoplasms

Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010