Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02384759
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 65 years
* General condition WHO ≤ 2
* Metastatic rectal or colonic adenocarcinoma, histologically proved on the primary tumour or a metastasis
* Metastases non-resectable and/or patient inoperable
* patients where a single agent chemotherapy combined with an anti-angiogenic agent is an appropriate approach
* At least one measurable target according to RECIST v1.1 criteria, no previously irradiated
* No previous treatment of the metastatic disease. Previous chemotherapy in an adjuvant situation completed 6 months or more before diagnosis of the metastasis is authorized.
* Adequate biological examination: Hb \> or = 9 g/dl, polynuclear neutrophils \> or = 1,500/mm3, platelets \> or =100,000/mm3, total bilirubin \< or = 1.5 x UNL, creatinine clearance, calculated according to Cockroft-Gault formula, \> 50 ml/min creatininemia \< 1.5 x UNL, ALP \< 5 x UNL, transaminases \< 5 x ULN, GGT\< 5 x UNL
* Proteinuria (strip) \< 2+; if \> or = 2+, test proteinuria over 24 hours which must be ≤ 1 g.
* Central genotyping of thymidylate synthase (TS) in blood DNA
* Patients treated with anticoagulants (coumadin, warfarin) can be included if the INR can be closely monitored. A change in anticoagulant treatment for low molecular weight heparin is preferable in order to respect indications
* Signed written informed consent obtained prior to inclusion
Exclusion Criteria:
* Patients with a primary tumour in place and presenting clinical symptoms (occlusion, haemorrhage)
* History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
* Uncontrolled hypercalcemia
* Uncontrolled hypertension (SBP \> 150 mmHg and DBP \> 100 mmHg) or history of hypertensive attacks or hypertensive encephalopathy
* Any progressive pathology not balanced over the past 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency,
* Any of the following within 6 months prior to inclusion: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
* Any of the following within 3 months prior to inclusion: Grade 3-4 gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event, wound or fractured bone
* Major surgery during the 28 days preceding the start of treatment
* Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
* Treatment with concomitant anticonvulsivant agents that are CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued \>7 days.
* Anti-tumoral treatments other than the trial treatments (chemotherapy, targeted therapy, immunotherapy)
* Macronodular peritoneal carcinosis (risk of perforation)
* Known DPD deficit
* Prior history of malignant haemopathy or cancer except those treated more than 5 years ago and considered to be cured, in situ cervical carcinomas and treated skin cancers (excluding melanoma)
* Patients on new oral anticoagulant therapy (rivaroxaban XARELTOR, apixaban ELIQUIS, dagigatran PRADAXA except if relay by vitamine K antagonist therapy)
* Any contraindication to the treatments used in the trial
* Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02384759
Study Brief:
Protocol Section:
NCT02384759