Titre |
A Randomized Trial of Five-Fraction Partial Breast Irradiation |
Protocole ID |
RAPID2 |
ClinicalTrials.gov ID |
NCT05417516 |
Type(s) de cancer |
Sein |
Phase |
|
Type étude |
Clinique |
Médicament |
Radiothérapie |
Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Tarek Hijal
|
Coordonnateur(trice) |
Marianna Perna
514-934-1934 poste 43191
|
Statut |
Actif en recrutement |
Date d'activation |
16-01-2024 |
Critètes d'éligibilité |
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease.(AJCC TNM Cancer Staging).
- Treated by BCS with microscopically clear resection margins ≥ 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection.
|
Critètes d'exclusion |
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size >3cm in greatest diameter on pathological examination.
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
|