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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT01023633
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed adenocarcinoma of the colon or rectum
* Unresectable metastases
* At least one bidimensionally measurable lesion of ≥ 1 cm
* No previous chemotherapy for metastatic disease; Completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
* 18-75 years old
* ECOG 0-2
* Life expectancy greater than 3 months
* Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L,
* Adequate Renal Function
* Adequate Liver Function
* Signed informed consent before the treatment
Exclusion Criteria:
* Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year
* Completely or partially bowel obstruction
* Presence of peripheral neuropathy (CTC\>grade I)
* Severe mental disorder
* CNS metastasis
* With other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
* With other malignant disease previously or concurrently
* Receive other anti-tumor treatment
* Pregnant or lactating women, or women of child bearing potential without contraceptive method.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01023633
Study Brief:
Protocol Section:
NCT01023633