Breast CancerORACLESNCT01183832
Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
An observational study of Breast Cancer, run by Centre Oscar Lambret at 29 sites in 2 countries.
Trial summary
This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 490 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Aug 2005to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are post-menopausal women treated for a breast concer
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
France28 sites
Centre Henri Becquerel
Amiens
Clinique La Casamance
Aubagne
Hôpital Duchêne
Boulogne-sur-Mer
Centre François Baclesse
Caen
Study site
Charleville
Henri Mondor
Créteil
Centre Oscar Lambret
Lille, 59020
Clinique Clairval
Marseille
Institut Paoli Calmettes
Marseille
La Timone
Marseille
Centre Val d'Aurelle
Montpellier
Centre Catherine de Sienne
Nantes
Centre Hospitalier St Grégoire
Nantes
Nouvelles cliniques nantaises
Nantes
Centre Antoine Lacassagne
Nice
Centre Antoine LACCASSAGNE
Nice
Clinique de la Roseraie
Paris
Hôpital Européen Georges Pompidou HEGP
Paris
Hôpital Pitié Salpêtrière
Paris
Hôpital Saint Louis
Paris
Centre Hospitalier LYON Sud
Pierre-Bénite
Polyclinique de Courlancy
Reims
Centre: Clinique Armoricaine de Radiologie
Saint-Brieuc
Centre René Huguenin
Saint-Cloud
Centre Paul Strauss
Strasbourg
Centre de radiothérapie Saint-Louis
Toulon
Centre Claudius REGAUD
Toulouse
Institut Gustave Roussy
Villejuif
About this study
This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, radiotherapy, hormonotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startAug 2005
- Primary completion13 Jan 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yazid BELKACEMI, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183832
- Sponsor's protocol ID
- ORACLES
- Acronym
- ORACLES
- Status last verified
- May 2019
- First submitted
- 16 Aug 2010
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy - Anastrazole Concomitant : Evaluation of the Side Effects
- ClinicalTrials.gov ID
- NCT01183832
- Acronym / sponsor ID
- ORACLES / ORACLES
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, radiotherapy, hormonotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- 13 Jan 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a description of the radiation effects on the healthy tissues in patients receiving Anastrozole, sequential or in association with radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are post-menopausal women treated for a breast concer
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yazid BELKACEMI, MD, PhD principal investigator
Centre Oscar Lambret
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Oscar Lambret at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation side effects (time frame: 5 years after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.