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ACTIVE NOT RECRUITING
NCT03878342
NA

Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

Sponsor: UNICANCER

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

295

Start Date

2019-05-10

Completion Date

2034-11-14

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

RADIATION

Radiotherapy

two fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines

OTHER

No Radiotherapy

No Irradiation- Active surveillance

Locations (37)

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

Hôpital René Huguenin - Institut Curie

Saint-Cloud, France

CHU Saint-Etienne

Saint-Etienne, 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