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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02384850
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
2. Patients who are feasible for treatment with FOLFOX (prior adjuvant or palliative treatment is allowed)
3. ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 1
4. Life expectancy \> 3 months
5. Age ≥18 years
6. Haematologic function as follows (5% deviation allowed):
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* platelets ≥ 100 x109/L
* hemoglobin ≥ 9 g/dl or 5.59 mmol/l
7. Adequate liver function as follows (10% deviation allowed)
* serum alanine transaminase (ALT) ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN)
* total bilirubin ≤ 1.5 x ULN (patients with Gilbert's syndrome total bilirubin ≤2.5 x ULN)
8. Adequate renal function as follows (10% deviation allowed)
· creatinine ≤ 1.5 x ULN
9. Signed written informed consent
10. Women of child-bearing potential must have a negative pregnancy test
Exclusion Criteria:
adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; 2. Treatment with any systemic anticancer therapy ≤ 3 weeks prior to cycle 1 day 1 3. Uncontrolled active infection (Hepatitis B and C infection are NOT exclusion criteria) and/or known HIV infection; 4. Renal failure requiring haemodialysis or peritoneal dialysis; 5. Patients who are pregnant or breast-feeding; 6. Patients with significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea resulting in inability to swallow oral medications; 7. Presence of symptomatic Central nervous system (CNS) metastasis 8. Unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery, in particular oxaliplatin-induced peripheral neuropathy \> grade 1.
9\. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02384850
Study Brief:
Protocol Section:
NCT02384850