CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Primary objective:
- Pathological complete response (ypT0N0) rate
Secondary objectives:
- Histopathological R0 resection rate
- Pathological downstaging (ypT0-T2N0) rate
- One month surgical complication rate
- Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
- Safety
- Local and distant recurrence rates
- Progression-free survival
- Overall survival
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
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No evidence of distant spread
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No prior therapy for chemotherapy or radiation therapy for rectal cancer
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Patient considered locally advanced by MRI:
- Tumour beyond mesorectal fascia, or
- Tumour ≤ 2mm from mesorectal fascia, or
- T3 tumour < 5cm from anal verge
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For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
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No peripheral neuropathy > grade1
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ECOG PS ≤ 2
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ANC > 1,500 x 10^9/L
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Platelets > 100,000 x 10^9/L
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Creatinine < 1.5 x IULN
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Bilirubin < 1.5 IULN
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SGPT (ALT) < 2.5 IULN
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No pre-existing condition which would deter chemoradiotherapy
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No uncontrolled diarrhoea or fecal incontinence
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No significant small bowel (> 200cc or 6X6X6cm) delineated within the radiation fields
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No other serious uncontrolled concomitant illness
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Informed consent signed
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
87 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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