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.