Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Radiotherapy

No Radiotherapy

Saliha GHANEM, PhD

Assia LAMRANI-GHAOUTI, PhD

Aurore GOINEAU, MD

Antoine ARNAUD, MD

Raphaël GAUZERE, MD

Adeline PETIT, MD

Julien GEFFRELOT, MD

Laure KALUZINSKI, MD

Aurélie BELLIERE, MD

Yazid BELKACEMI, MD

Karine PEIGNAUX, MD

Shakeel SUMODHEE

David PASQUIER, MD

Pierre CLAVERE, MD

Guillaume BERA, MD

Séna YOSSI

Jessica SERRAND, MD

Marion CORTET, MD

Claire LEMANSKI, MD

Philippe RONCHIN, MD

Marie-Eve CHAND FOUCHE, MD

Nathalie PINTO, MD

Philippe MAINGON, MD

Alain FOURQUET, MD

Pierre-Adrien BOLZE, MD

Philippe GUILBERT, MD

Isabelle LECOUILLARD, MD

Sandrine MEZZANI SAILLARD, MD

Omar JMOUR, MD

Anne KARST PROVOT, MD

Inès MENOUX, MD

Ciprian CHIRA, MD

Claire CHARRA BRUNAUD, MD

Sofia RIVERA, MD

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.

Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

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

Incidence of breast recurrence is determined from the date of last surgery to the date of breast recurrence.

OS is defined as the interval between the date of last surgery and the date of death from any cause;

BCSS is defined as the interval between the date of last surgery and the date of death from breast cancer

RFS is defined as the interval between the date of last surgery and the date of ipsilateral breast recurrence, regional nodes recurrence, distant metastases, of death from breast cancer, whichever occurs first

In-breast recurrence defined as any carcinoma (invasive or in situ) occurring in the treated breast

Contralateral breast cancer defined as any carcinoma (invasive or in situ) occurring in the contralateral breast.

Quality of life will be assessed using QLQ-C 30 questionnaire from the European Organization for Research and Treatment of Cancer (EORTC). It is a 30-item self-reporting questionnaire developed to assess the quality of life of cancer patients. It is grouped into five functional subscales (role, physical, cognitive, emotional and social functioning). In addition, there are three multi-item symptom scales (fatigue, pain, and nausea and vomiting), individual questions concerning common symptoms in cancer patients,and two questions assessing overall Quality of Life

Quality of Life of Patients will be assessed using a EORTC-QLQ BR23.It is a 23-item self-reporting specific questionnaire developed to assess the quality of life of breast cancer patients. It permits to evaluate the symptoms of breast cancer and the side effects of treatment.

cosmetic results will be evaluated by centralized photographic analysis.

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders and so the late effects and sequelea regarding the whole-breast radiotherapy.

National Cancer Institute, France

UNICANCER

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast	NCT03878342	DCIS Breast Cancer Low Risk DCIS Breast Conservi... Radiotherapy Om...	Radiotherapy No Radiotherapy	50 Years -	UNICANCER
Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast	NCT03878342	DCIS Breast Cancer Low Risk DCIS Breast Conservi... Radiotherapy Om...	Radiotherapy No Radiotherapy	50 Years -	UNICANCER

Spots Global Cancer Trial Database for low risk dcis