Clinical trial NCT01183832: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
Official title: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
radiotherapy
hormonotherapy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 490
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are post-menopausal women treated for a breast concer

Brief summary: This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal woman without superior age limit
* No metastatic breast cancer, stade I-II, estrogen receptor positive or progesterone receptor positive, treated by conservative surgery or total mastectomy and requiring additive treatment by radiotherapy and hormonotherapy
* The patients including in another clinical trial can be include in this observatory

Primary outcomes:
measure: radiation side effects
timeFrame: 5 years after the end of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Henri Becquerel
city: Aubagne
country: France
facility: Clinique La Casamance
city: Boulogne-sur-Mer
country: France
facility: Hôpital Duchêne
city: Caen
country: France
facility: Centre François Baclesse
city: Charleville
country: France
city: Creteil
country: France
facility: Henri Mondor
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: Clinique Clairval
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: La Timone
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nantes
country: France
facility: Centre Hospitalier St Grégoire
city: Nantes
country: France
facility: Nouvelles cliniques nantaises
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Centre Antoine LACCASSAGNE
city: Paris
country: France
facility: Clinique de la Roseraie
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou HEGP
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre Benite
country: France
facility: Centre Hospitalier LYON Sud
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Saint-cloud
country: France
facility: Centre René Huguenin
city: St BRIEUC
country: France
facility: Centre: Clinique Armoricaine de Radiologie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulon
country: France
facility: Centre de radiothérapie Saint-Louis
city: Toulouse
country: France
facility: Centre Claudius REGAUD
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Monaco
country: Monaco
facility: Centre CHPG
Study officials:
affiliation: Centre Oscar Lambret
name: Yazid BELKACEMI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: