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 CHU DE QUEBEC
1401 18e Rue
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Valérie Théberge
COORDONATEUR(RICE) Josée Allard
418-525-4444 poste 67296
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.