Breast Cancer Clinical Trial
— ORACLESOfficial title:
Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
| NCT number | NCT01183832 |
| Other study ID # | ORACLES |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2005 |
| Est. completion date | January 2016 |
| Verified date | May 2019 |
| Source | Centre Oscar Lambret |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.
| Status | Completed |
| Enrollment | 490 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 13, 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Henri Becquerel | Amiens | |
| France | Clinique La Casamance | Aubagne | |
| France | Hôpital Duchêne | Boulogne-sur-Mer | |
| France | Centre François Baclesse | Caen | |
| France | Henri Mondor | Creteil | |
| France | Centre Oscar Lambret | Lille | |
| France | Clinique Clairval | Marseille | |
| France | Institut Paoli Calmettes | Marseille | |
| France | La Timone | Marseille | |
| 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 | |
| Monaco | Centre CHPG | Monaco |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Oscar Lambret |
France, Monaco,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | radiation side effects | 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 |
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