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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT01532804
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven colorectal cancer
* Resected or asymptomatic primary tumor
* Metastatic colorectal cancer not eligible for curative surgery
* No major surgery within four weeks of the start of study treatment
* At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
* Disease progression after failure of irinotecan-based chemotherapy
* Bone metastases are allowed if there is at least one other measurable metastatic site
* CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
* WHO PS ≤ 2
* Platelet count \>= 100,000 mm3
* Hemoglobin \> 10g/dl
* Bilirubin \< 1.5 ULN, AST/ALT \< 5 ULN
* Serum creatinine \< 1.5 ULN, creatinine clearance \> 60 ml/min (Cockcroft)
* A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
* Negative pregnancy test in women of childbearing potential
* Male or female using an effective contraceptive method
* Absence of known or symptomatic brain metastases
* Life expectancy \> 3 months
* Informed consent signed prior any study specific procedures
Exclusion Criteria:
* Prior raltitrexed-based chemotherapy
* Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
* Uncontrolled arterial hypertension defined as systolic pressure \> 150 mm Hg or diastolic pressure \> 100 mm Hg
* Malignant hypertension or hypertensive encephalopathy
* Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
* Hemorrhagic diathesis or significant pathology of coagulation
* Peripheral neuropathy grade\>2 (NCI-CTC v4.0)
* Hemoptysis \< 1 month
* Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
* Symptomatic brain metastases or carcinomatous meningitis
* History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
* Severe bacterial or fungal infection (Grade \> 2 NCI-CTCAE v.4.0)
* Known or suspected sensitivity to one of the study drugs
* Pregnant or breastfeeding women
* Previous enrollment in an investigational drug study within the last 4 weeks
* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01532804
Study Brief:
Protocol Section:
NCT01532804