Other: Early tumor response evaluation by MRI volumetry
Radiation: Radiochemotherapy Cap 50
Radiation: Radiochemotherapy Cap 60
Procedure: Radical proctectomy with total mesorectal excision
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Full eligibility criteria for NCT01333709
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Histologically confirmed rectal carcinoma
Primary tumor evaluated by pelvic MR Imaging: i) iT3 ≥c tumors, with MRI showing a predictive CRM ≤ 2 mm or a EMS (Extra Mural Spread) ≥ 5 mm ii) Resectable iT4 tumors (only randomized within the "poor responders" group) iii) Any T tumors with MRI showing a predictive CRM ≤ 1 mm
No detectable metastases: Thorax-abdomen-pelvic CT-scan
Patient ≥ 18 years
ECOG Performance Status 0-1-2
Patient information and written informed consent form signed
Patient who can receive radiotherapy and chemotherapy
Negative pregnancy test in women of childbearing potential
Patient covered by a Social Security system
Hematology : Haemoglobin ≥ 9 g/dL, WBC ≥ 4000/mm3, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
Hepatic function : total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN
Renal function : creatinine ≤ 1.25 x ULN or creatinine clearance ≥ 60 ml/min
Indication for immediate surgery
Primary tumor not measured at the MRI before inclusion
Previous pelvic radiotherapy
Contraindication to radiotherapy and/or chemotherapy
Severe renal or liver impairment
Cardiac and/or coronary disease which could contraindicate 5-Fu administration
Active infectious disease
Peripheral sensitive neuropathy
History of prior cancer (except if it was cured more than 5 years ago, and if complete remission)
Patient (male or female) of reproductive potential not using an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment
Concurrent participation in any other clinical trial likely to interfere with the therapeutic schedule
Fertile female patient not using adequate contraception, or breast-feeding woman
All locations for NCT01333709
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298
View full eligibility
Tris trial is registered with FDA with number: NCT01333709. The sponsor of the trial is Institut du Cancer de Montpellier - Val d'Aurelle and it is looking for 150 volunteers for the current phase.
Official trial title: A Randomized Multicenter Phase 2 Study: a Tailored Strategy for Locally Advanced Rectal Carcinoma
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