Metastatic Colorectal Adenocarcinoma
Conditions
Brief summary
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.
Interventions
DRUGLV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
DRUGLV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 75 years or older * ECOG ≤2 * histologically proven unresectable metastatic colorectal adenocarcinoma * Measurable lesion according to RECIST criteria * Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously * Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected * Completed geriatric self-questionnaire * Completed Team geriatric questionnaire (including Spitzer QoL Index) * Written informed consent
Exclusion criteria
* Estimated life expectancy \< 3 months * Non-resolved intestinal occlusion or sub-occlusion * Cerebral metastasis * Other evolutive malignant tumor (non-stabilized cancer for less than 2 years) * Evolutive gastroduodenal ulcer, wound or bone fracture * Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure * Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment * Polynuclear neutrophils \<1500/mm3, platelets \<100 000/mm3 or 24-h proteinuria \> 1g * History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab * History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab * History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab * Impossibility to ensure regular follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial examination | 21 days before the first course of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial examination | 14 days before inclusion | 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. |
Countries
France
Outcome results
None listed