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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01183832
First received: August 16, 2010
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

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


Enrollment: 490
Study Start Date: August 2005
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Genders 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183832

Locations
France
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
Nouvelles cliniques nantaises
Nantes, France
Centre Catherine de Sienne
Nantes, France
Centre Hospitalier St Grégoire
Nantes, France
Centre Antoine Lacassagne
Nice, France
Centre Antoine LACCASSAGNE
Nice, France
Hôpital Européen Georges Pompidou HEGP
Paris, France
Hôpital Saint Louis
Paris, France
Hôpital Pitié Salpêtrière
Paris, France
Clinique de la Roseraie
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
Investigators
Principal Investigator: Yazid BELKACEMI, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01183832     History of Changes
Other Study ID Numbers: ORACLES
Study First Received: August 16, 2010
Last Updated: July 20, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Oscar Lambret:
Breast cancer
radiotherapy
hormonotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014