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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT01543412
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent prior to beginning protocol specific procedures
* Previous chemotherapy with Gemcitabine plus or less Platinoids
* Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed.
* Male or female less than 75 years of age
* Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced (non-resectable) or metastatic pancreatic cancer
* Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
* ECOG performance status 0 to 1 at study entry
* Life expectancy: more than 3 months
* Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL
* Bilirubin level either normal or less than 1.5 x ULN
* ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present)
* Serum creatinine less than 1.5 x ULN
* Amylase normal or less than 1.5 ULN
* Effective contraception for both male and female patients if the risk of conception exists
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
Exclusion Criteria:
* Brain metastases
* Previous treatment with irinotecan or fluoropyrimidines
* Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
* Significant gastrointestinal abnormalities
* Gilbert's Syndrome
* Any uncontrolled infections
* Known HIV infection
* Radiotherapy within 4 weeks prior to study entry
* Any investigational agents 4 weeks prior to entry
* Known grade 3 or 4 allergic reaction to any of the components of the treatment
* Known drug abuse or alcohol abuse
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
* Women who are pregnant or breastfeeding
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01543412
Study Brief:
Protocol Section:
NCT01543412