TITRE (EN) Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer
PROTOCOLE ID EMBRACE 2
CLINICAL TRIAL.gov ID NCT03617133
TYPE(S) DE CANCER Col
PHASE Phase II
TYPE D'ÉTUDE Traitement
INSTITUTION CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Israël Fortin
COORDONATEUR(RICE) Véronique Tran
veronique.tran.cemtl@ssss.gouv.qc.ca
514-252-3400 poste 3227
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT
  • Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
  • Staging according to FIGO and TNM guidelines
  • MRI of pelvis at diagnosis is performed
  • MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
  • MRI with the applicator in place at the time of (first) BT will be performed
  • Para-aortic metastatic nodes below L1-L2 are allowed
  • Patient informed consent
CRITÈRES D'EXCLUSION (EN)
  • Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
  • Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
  • Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace
  • Previous pelvic or abdominal radiotherapy
  • Previous total or partial hysterectomy
  • Combination of preoperative radiotherapy with surgery
  • Patients receiving BT only
  • Patients receiving EBRT only
  • Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy.
  • Contra indications to MRI
  • Contra indications to BT