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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT01063192
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
2. Patients must have locally advanced pancreatic cancer (LAPC).
3. Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
4. Patients must have measurable disease.
5. Age \>20 years.
6. ECOG performance scale of 0-2.
7. Patients must have normal organ and marrow function.
8. Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
9. The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
10. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Patients with distant metastases are not eligible.
2. Patients may not be receiving any other investigational agents.
3. Patients who have had prior chemotherapy or radiotherapy are not eligible.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
5. Patients who have above grade II peripheral neuropathy.
6. Patients who had non-curable second primary malignancy.
7. Uncontrolled intercurrent illness including.
8. Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects.
9. Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01063192
Study Brief:
Protocol Section:
NCT01063192