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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT00112658
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* No other pancreatic tumor type, including either of the following:
* Neuroendocrine tumor
* Acinar cell tumor
* Metastatic disease
* Measurable disease in an area not previously irradiated
* No cerebral metastases or meningeal involvement of the tumor
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)
Renal
* Creatinine \< 120 mmol/L
Cardiovascular
* No prior myocardial infarction
* No prior angina
* No uncompensated cardiac or coronary insufficiency
* No symptomatic arrhythmia
Gastrointestinal
* No prior inflammatory bowel disease
* No prior chronic diarrhea
* No unresolved symptomatic occlusion or subocclusion of the bowel
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No ongoing active infection
* No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindication to study treatment
* No other serious medical disorder that would preclude study treatment
* No psychiatric disorder or social or geographic situation that would preclude study participation
* Not detained or under the guardianship of another person
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* Not specified
Other
* No concurrent participation in another clinical trial using therapeutic experimental agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00112658
Study Brief:
Protocol Section:
NCT00112658