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

May 29, 2019 updated by: Centre Oscar Lambret
This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Centre Henri Becquerel
      • Aubagne, France
        • Clinique La Casamance
      • Boulogne-sur-Mer, France
        • Hôpital Duchêne
      • Caen, France
        • Centre Francois Baclesse
      • Charleville, France
      • Creteil, France
        • Henri Mondor
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • Clinique Clairval
      • Marseille, France
        • La Timone
      • Montpellier, France
        • Centre Val d'Aurelle
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nantes, France
        • Centre Catherine de Sienne
      • Nantes, France
        • Centre Hospitalier St Grégoire
      • Nice, France
        • Centre Antoine Lacassagne
      • Nice, France
        • Centre Antoine Laccassagne
      • Paris, France
        • Hôpital Pitié Salpetrière
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Clinique de la Roseraie
      • Paris, France
        • Hopital europeen Georges Pompidou HEGP
      • Pierre Benite, France
        • Centre Hospitalier Lyon Sud
      • Reims, France
        • Polyclinique de Courlancy
      • Saint-cloud, France
        • Centre Rene Huguenin
      • St BRIEUC, France
        • Centre: Clinique Armoricaine de Radiologie
      • Strasbourg, France
        • Centre Paul Strauss
      • Toulon, France
        • Centre de radiothérapie Saint-Louis
      • Toulouse, France
        • Centre Claudius Regaud
      • Villejuif, France
        • Institut Gustave Roussy
  • Monaco
      • Monaco, Monaco
        • Centre CHPG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients are post-menopausal women treated for a breast concer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Concomitant
In this group, anastrazole is concomitant to the radiotherapy
Sequential
In this group, anastrazole is sequential to the radiotherapy (start after the end of radiotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Yazid BELKACEMI, MD, PhD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

January 13, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORACLES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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