Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects (ORACLES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183832
Recruitment Status : Unknown
Verified August 2014 by Centre Oscar Lambret.
Recruitment status was:  Active, not recruiting
First Posted : August 18, 2010
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
Study Start Date : August 2005
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

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

Primary Outcome Measures :
  1. radiation side effects [ Time Frame: 5 years after the end of radiotherapy ]
    Describe, in real situation, the ionisant radiation effects on the healthy tissues in patients receiving anastrazole in association or sequential with radiotherapy

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are post-menopausal women treated for a breast concer

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01183832

Centre Henri Becquerel
Amiens, France
Clinique La Casamance
Aubagne, France
Hôpital Duchêne
Boulogne/Mer, France
Centre François Baclesse
Caen, France
Charleville, France
Henri Mondor
Creteil, France
Centre Oscar Lambret
Lille, France, 59020
Clinique Clairval
Marseille, France
Institut Paoli Calmettes
Marseille, France
La Timone
Marseille, France
Centre CHPG
Monaco, France
Centre Val d'Aurelle
Montpellier, France
Centre Catherine de Sienne
Nantes, France
Centre Hospitalier St Grégoire
Nantes, France
Nouvelles cliniques nantaises
Nantes, France
Centre Antoine Lacassagne
Nice, France
Centre Antoine LACCASSAGNE
Nice, France
Clinique de la Roseraie
Paris, France
Hôpital Européen Georges Pompidou HEGP
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Hôpital Saint Louis
Paris, France
Centre Hospitalier LYON Sud
Pierre Benite, France
Polyclinique de Courlancy
Reims, France
Centre René Huguenin
Saint-cloud, France
Centre: Clinique Armoricaine de Radiologie
St BRIEUC, France
Centre Paul Strauss
Strasbourg, France
Centre de radiothérapie Saint-Louis
Toulon, France
Centre Claudius REGAUD
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Centre Oscar Lambret
Principal Investigator: Yazid BELKACEMI, MD, PhD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret Identifier: NCT01183832     History of Changes
Other Study ID Numbers: ORACLES
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014

Keywords provided by Centre Oscar Lambret:
Breast cancer

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs