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
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| 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 | |
| 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 May 19, 2013