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Spots Global Cancer Trial Database for Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

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Trial Identification

Brief Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

Official Title: Prospective Study of Omission of Whole-breast Radiotherapy Following Breast-conserving Surgery in Patients With Very Low Risk Ductal Carcinoma in Situ of the Breast

Study ID: NCT03878342

Study Description

Brief Summary: Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences. Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p \<0.001). Sixty percent of the patients received tamoxifen in both groups. Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk. Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management.

Detailed Description:

Keywords

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Institut de Cancérologie de l'Ouest -Site Paul Papin, Angers, , France

Institut Sainte Catherine, Avignon, , France

Centre d'Oncologie et de Radiothérapie du Pays Basque, Bayonne, , France

Clinique Belharra, Bayonne, , France

Institut Bergonie, Bordeaux, , France

Centre Francois Baclesse, Caen, , France

Centre Hospitalier du Cotentin, Cherbourg, , France

Centre Jean Perrin, Clermont-Ferrand, , France

CHIC Créteil, Créteil, , France

Hôpital Henri Mondor, Créteil, , France

Centre Georges Francois Leclerc, Dijon, , France

Centre Hospitalier De Lagny Sur Marne, Jossigny, , France

CHU Saint-Pierre La Réunion, La Réunion, , France

Centre Guillaume le Conquérant, Le Havre, , France

Centre Oscar Lambret, Lille, , France

Chu De Limoges - Hopital Dupuytren, Limoges, , France

Centre Hospitalier Bretagne Sud, Lorient, , France

Centre de Radiothérapie Mermoz, Lyon, , France

Centre Léon Berard, Lyon, , France

Hôpital La Croix Rousse, Lyon, , France

Institut Regional Du Cancer Montpellier Val D Aurelle, Montpellier, , France

Centre Azuréen De Cancérologie, Mougins, , France

Centre Antoine Lacassagne, Nice, , France

Centre de Haute Energie, Nice, , France

Hopital Pitie Salpetriere, Paris, , France

Institut CURIE, Paris, , France

Centre Hospitalier Lyon Sud, Pierre-Bénite, , France

Institut Jean Godinot, Reims, , France

Centre Eugène Marquis, Rennes, , France

Centre Frédéric Joliot, Rouen, , France

Centre Henri Becquerel, Rouen, , France

Hôpital René Huguenin - Institut Curie, Saint-Cloud, , France

CHU Saint-Etienne, Saint-Étienne, , France

Centre De Radiothérapie De La Robertsau, Strasbourg, , France

Centre Paul Strauss, Strasbourg, , France

Institut Claudius Regaud, Toulouse, , France

Institut De Cancerologie De Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, , France

Gustave Roussy, Villejuif, , France

Contact Details

Name: Alain FOURQUET, MD

Affiliation: Institut Curie

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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