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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT01882868
Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically proven adenocarcinoma of the colon or rectum.
* Metastatic disease that was not amenable to potentially curative treatment.
* Participants with measurable disease.
* One prior chemotherapeutic regimen (containing oxaliplatin) for metastatic disease.
* Participants who relapsed within 6 months of completion of oxaliplatin-based adjuvant chemotherapy were also eligible.
Exclusion criteria:
* Prior therapy with irinotecan.
* Less than 28 days elapsed from prior radiotherapy, prior surgery, or prior chemotherapy to the time of registration.
* Unresolved toxicity (grade \>1) from prior anticancer therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status \>1.
* Brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis.
* Other prior malignancy.
* Pregnant or breast-feeding women.
* Uncontrolled hypertension.
* Inadequate bone marrow function, liver function, or renal function.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01882868
Study Brief:
Protocol Section:
NCT01882868