|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
NCT01247233 |
|
Date of registration:
|
26/10/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI)for Breast Cancer
SHARE |
|
Scientific title:
|
Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer |
|
Date of first enrolment:
|
October 2010 |
|
Target sample size:
|
2796 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01247233 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Jerome LEMONNIER, PhD |
|
Address:
|
|
|
Telephone:
|
+33 1 7193 6702 |
|
Email:
|
j-lemonnier@unicancer.fr |
|
Affiliation:
|
|
|
|
Name:
|
Yazid Belkacemi, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Henri Mondor Hospital AP-HP, Créteil, France |
|
|
Name:
|
Céline Bourgier, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut de Cancérologie de Montpellier, Montpellier, France |
|
|
Name:
|
Eric Lartigau, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oscar Lambret Hospital, Lille, France |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Women aged = 50 years
- Menopausal status confirmed
- Pathology confirmation of invasive carcinoma (all types)
- Complete tumor removal and conservative surgery
- Pathologic tumor size of invasive carcinoma = 2cm (including the in situ component)
pT1
- All histopathologic grades
- Clear lateral margins for the invasive and in situ disease (> 2mm)
- pN0 or pN(i+)
- No metastasis
- Radiotherapy should be started more than 4 weeks and less than 12 weeks after last
surgery
- Surgical clips (4 to 5 clips in the tumor bed)
- No prior breast or mediastinal radiotherapy
- ECOG 0-1
- Information to the patient and signed informed consent
Exclusion Criteria:
- Multifocal invasive ductal carcinoma defined as the presence of at least two distinct
tumors that are separated by normal tissue or when the distance between the two
lesions does not permit conservative surgery
- Bilateral breast cancer
- No or less than 4 surgical clips in the tumor bed
- Nodal involvement : pN1 (including micrometastasis, mi+), pN2, pN3
- Metastatic disease
- internal mammary node involvement or supraclavicular lymph node involvement
- Indication of chemotherapy or trastuzumab
- Involved or close lateral margins for the invasive and /or in situ components (< 2mm)
AND impossibility to re-operate or impossible to perform another conservative surgery
- Patients with known BRCA1 or BRCA2 mutations
- Previous mammoplasty
- Previous homolateral breast and/or mediastinal irradiation
- Previous invasive cancer (except basocellular epithelioma or in situ carcinoma of the
cervix)
- No geographical, social or psychologic reasons that would prevent study follow
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Lumpectomy
|
|
Intervention(s)
|
|
Radiation: Accelerated partial breast irradiation
|
|
Radiation: Hypofractionated WBI
|
|
Radiation: Whole Breast Irradiation + Boost
|
|
Primary Outcome(s)
|
|
rate of local recurrence
[Time Frame: 5 years]
|
|
Secondary Outcome(s)
|
|
Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)
[Time Frame: 10 years]
|
|
Disease-specific survival
[Time Frame: 10 years]
|
|
Distant recurrence-free survival
[Time Frame: 10 years]
|
|
Ipsilateral breast recurrence-free survival
[Time Frame: 10 years]
|
|
Medico-economic study
[Time Frame: 3 years]
|
|
Nodal regional recurrence-free survival
[Time Frame: 10 years]
|
|
Overall survival
[Time Frame: 10 years]
|
|
Quality of Life and Satisfaction
[Time Frame: 10 years]
|
|
Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)
[Time Frame: 10 years]
|
|
Secondary ID(s)
|
|
2010-A00243-36
|
|
RTS02 / SHARE
|
|
RTS02-SHARE
|
|
UC-0140/1001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|