Titre |
Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer |
Protocole ID |
EMBRACE 2 |
ClinicalTrials.gov ID |
NCT03617133 |
Type(s) de cancer |
Col |
Phase |
Phase II |
Stade |
Localement avancé |
Type étude |
Traitement |
Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Israël Fortin
|
Coordonnateur(trice) |
Véronique Tran
514-252-3400 poste 3227
|
Statut |
Actif en recrutement |
Critètes d'éligibilité |
-
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.
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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
|
Critètes d'exclusion |
-
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
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Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace
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Previous pelvic or abdominal radiotherapy
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Previous total or partial hysterectomy
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Combination of preoperative radiotherapy with surgery
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Patients receiving BT only
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Patients receiving EBRT only
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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.
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Contra indications to MRI
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Contra indications to BT
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