| Title |
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 |
| ClinicalTrials.gov ID |
|
| Cancer Type(s) |
Breast |
| Phase |
Phase I-II |
| Stage |
|
| Study Type |
|
| Drug |
aucun |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| City |
Montréal |
| Principal Investigator |
Dr. Michael Yassa
|
| Coordinator |
Véronique Tran
514-252-3400 poste 3227
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
-
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
|
| Exclusion Criteria |
-
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
|
| |
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Groupe d'étude en oncologie du Québec