Breast Cancer
Conditions
Keywords
breast cancer, radiotherapy, intensity modulation, toxicity
Brief summary
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.
Detailed description
Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient. The therapeutic support and monitoring are standard.
Interventions
None listed
Sponsors
Centre Oscar Lambret
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient
Exclusion criteria
1. \- Metastatic disease 2. \- Patient having another severe disease or uncontrolled which could jeopardize the trial participation 3. \- pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute and tardive toxicity according to NCI-CTCAE v4.0 | up to 5 years | according to NCI-CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life according to QLQC-30 | up to 24 months | Quality of life according to QLQC-30 |
| Quality of life according to BR-23 module | up to 24 months | Quality of life according to BR-23 module |
| Disease free survival | up to 5 years | according to RECIST 1.1 |
| esthetic results | up to 5 years | by physician and patient according to a scale (good, excellent, moderate and poor) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDavid PASQUIER, MD
Centre Oscar Lambret
Outcome results
None listed