To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older. This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
102
CHU de Dijon
Dijon, France
Initial examination
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.
Time frame: 21 days before the first course of treatment
Initial examination
Medical history, clinical examination (HR, arterial blood pressure , temperature, weight, height, Eastern Cooperative Oncology Group performance status), * measurement of body surface area, ECG * completion of questionnaire by the patient (annexe 1), * completion of geriatric questionnaire "team" (annexe 2) * biological examination including: * full blood count-platelets * blood electrolyte panel, creatinemia * Albumin * ASAT, ALAT, PAL, GGT, total and conjugated bilirubin * CEA, CA 19.9, LDH markers * balanced INR for patients on AVK * Urinary dip with 24-hour proteinuria if \> 1+ * Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)), * In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.
Time frame: 14 days before inclusion
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