Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects

NCT ID: NCT01183832

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Concomitant

In this group, anastrazole is concomitant to the radiotherapy

No interventions assigned to this group

Sequential

In this group, anastrazole is sequential to the radiotherapy (start after the end of radiotherapy)

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yazid BELKACEMI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Centre Henri Becquerel

Amiens, , France

Site Status

Clinique La Casamance

Aubagne, , France

Site Status

Hôpital Duchêne

Boulogne-sur-Mer, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Charleville, , France

Site Status

Henri Mondor

Créteil, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Clinique Clairval

Marseille, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

La Timone

Marseille, , France

Site Status

Centre Val d'Aurelle

Montpellier, , France

Site Status

Centre Catherine de Sienne

Nantes, , France

Site Status

Centre Hospitalier St Grégoire

Nantes, , France

Site Status

Nouvelles cliniques nantaises

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Centre Antoine LACCASSAGNE

Nice, , France

Site Status

Clinique de la Roseraie

Paris, , France

Site Status

Hôpital Européen Georges Pompidou HEGP

Paris, , France

Site Status

Hôpital Pitié Salpêtrière

Paris, , France

Site Status

Hôpital Saint Louis

Paris, , France

Site Status

Centre Hospitalier LYON Sud

Pierre-Bénite, , France

Site Status

Polyclinique de Courlancy

Reims, , France

Site Status

Centre: Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Site Status

Centre René Huguenin

Saint-Cloud, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Centre de radiothérapie Saint-Louis

Toulon, , France

Site Status

Centre Claudius REGAUD

Toulouse, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Centre CHPG

Monaco, , Monaco

Site Status

Countries

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France Monaco

Other Identifiers

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ORACLES

Identifier Type: -

Identifier Source: org_study_id

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