| TITRE |
Une étude de phase I-II évaluant la radiothérapie préopératoire en une seule fraction pour les femmes atteintes d’un cancer du sein de stade précoce |
| PROTOCOLE ID |
SPORT DS |
| CLINICAL TRIAL.gov ID |
|
| TYPE(S) DE CANCER |
Sein |
| PHASE |
Phase I-II |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Michael Yassa
|
| COORDONATEUR(RICE) |
Véronique Tran
veronique.tran.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 3227
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Female aged 65 years or older
- World Health Organization (WHO) performance status 0-2
- Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start
- Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start
- Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound
- No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound
- Estrogen receptor status (ER) positive on biopsy
- Her2 negative on biopsy
- Grade 1 or 2 on biopsy
- Planned surgery is a partial mastectomy with sentinel lymph node biopsy
- Localisation markers placed before treatment
|
| CRITÈRES D'EXCLUSION |
(EN)
- Age less than 65 years
- A known deleterious mutation in BRCA 1 and/or BRCA 2
- Clinical tumor size > 2.0 cm in greatest diameter on staging ultrasound
- Tumor histology limited to lobular carcinoma only
- Clinically positive axillary nodes (cN+)
- Lymphovascular invasion on biopsy
- Pure ductal or lobular carcinoma in situ on biopsy
- Extensive intraductal component on biopsy
- Neoadjuvant hormonal manipulation or chemotherapy
- Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial)
- More than one primary tumor in different quadrants of the same breast
- Diffuse microcalcifications on mammography
- Paget’s disease of the nipple
- Previous irradiation to the ipsilateral breast
- Presence of an ipsilateral breast implant or pacemaker
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
- Estrogen receptor status (ER) not known
- Currently pregnant or lactating
- Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol
- Geographic inaccessibility for follow-up
- Lack of preoperative staging with breast and axillary ultrasound
- Inability to adequately plan the patient for the experimental technique
|
