| TITRE |
(EN) A Randomized Trial of Five-Fraction Partial Breast Irradiation |
| PROTOCOLE ID |
RAPID2 |
| CLINICAL TRIAL.gov ID |
NCT05417516 |
| TYPE(S) DE CANCER |
Sein |
| PHASE |
|
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Tarek Hijal
|
| COORDONATEUR(RICE) |
Marianna Perna
marianna.perna@muhc.mcgill.ca
514-934-1934 poste 43191
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
