Title |
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 |
Cancer Type(s) |
Cervix |
Phase |
Phase II |
Stage |
Locally advanced |
Study Type |
Treatment |
Drug |
|
Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
City |
Montréal |
Principal Investigator |
Dr. Israël Fortin
|
Coordinator |
Véronique Tran
514-252-3400 poste 3227
|
Status |
Recruiting |
Activation Date |
|
Eligibility Criteria |
-
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
-
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
-
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
|
Exclusion Criteria |
-
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
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Previous total or partial hysterectomy
-
Combination of preoperative radiotherapy with surgery
-
Patients receiving BT only
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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
|
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