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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01417494
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Unresectable disease
* Measurable disease by RECIST criteria
* No cerebral metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* Polynuclear neutrophils \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Proteinuria ≤ 1 g on 24-hour urine collection
* No unresolved intestinal occlusion or subocclusion
* No other progressive or unstabilized malignant tumor within the past 2 years
* No progressive gastroduodenal ulcer, wound, or bone fracture
* No active cardiac disease including any of the following:
* Hypertension not adequately controlled
* Myocardial infarction within the past 6 months
* Poorly controlled angina
* Decompensated congestive cardiac insufficiency
* No history of arterial thromboembolism or any of the following within the past 12 months:
* Cerebrovascular accident
* Transient ischemic attack
* Subarachnoid hemorrhage
* No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
* No history of life-threatening pulmonary embolism within the past 6 months
* Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for metastatic disease
* More than 6 months since adjuvant chemotherapy after resection of the primary tumor
* More than 4 weeks since major surgery, excluding biopsy
* More than 4 weeks since radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Maximum Age:
120 Years
Study:
NCT01417494
Study Brief:
Protocol Section:
NCT01417494