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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT01321957
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
2. Patients with at least one measurable lesion, with size \> 1 cm (RECIST v1.1)
3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
4. Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
5. Life expectancy \> 3 months
6. Age ≥ 18 years
7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
* 9 g/dl or 5.59 mmol/l
8. Patients not receiving therapeutic anticoagulation must have an INR \< 1.5 ULN and aPTT \< 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
9. Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN) and total bilirubin ≤ 1.5 x ULN
10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
11. Signed, written informed consent
Exclusion Criteria:
1. Patients with histologically confirmed diagnosis of stage IV (UICC) colorectal cancer (primary tumor may be present)
2. Patients with at least one measurable lesion, with size \> 1 cm (RECIST v1.1)
3. ECOG Performance status ≤ 2 (ECOG 2, only if tumor related)
4. Patients, who are able to tolerate intensive first lien treatment as judged by the investigator
5. Life expectancy \> 3 months
6. Age ≥ 18 years
7. Haematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x109/L, hemoglobin
* 9 g/dl or 5.59 mmol/l
8. Patients not receiving therapeutic anticoagulation must have an INR \< 1.5 ULN and aPTT \< 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.
9. Adequate liver function as measured by serum transaminases (AST \& ALT) ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN) and total bilirubin ≤ 1.5 x ULN
10. Adequate renal function: Serum creatinine ≤ 1.5 x ULN
11. Signed, written informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01321957
Study Brief:
Protocol Section:
NCT01321957