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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00438256
Eligibility Criteria:
Inclusion Criteria:
* Cytologic of histologic proof of pancreatic ductal carcinoma
* No evidence of metastatic disease
* 18 years of age or older
* ECOG Performance Status of 0 or 1 - Lab values as outlined in the protocol
Exclusion Criteria:
* Tumors in the body or tail of the pancreas
* Hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
* Serious concomitant systemic disorders incompatible with the study, such as significant cardiac or pulmonary morbidity, ongoing infection as manifested by fever
* Pregnant or lactating women
* Life expectancy of \< 3 months
* Serious, uncontrolled, concurrent infection (s)
* Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Other serious uncontrolled medical condition that the investigator feels might compromise study participation
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Known, existing uncontrolled coagulopathy
* Any prior fluoropyrimidine therapy
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to a 5-fluorouracil or known DPD deficiency
* Participation in any investigational drug study within 4 weeks preceding the start of the study
* History of uncontrolled seizures, central nervous system disorders or psychiatric disability
* Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
* Patients on cimetidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00438256
Study Brief:
Protocol Section:
NCT00438256