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)
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Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT
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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
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MRI of pelvis at diagnosis is performed
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MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
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MRI with the applicator in place at the time of (first) BT will be performed
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Para-aortic metastatic nodes below L1-L2 are allowed
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Patient informed consent
|
CRITÈRES D'EXCLUSION |
(EN)
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Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
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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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