A Study of Locally Advanced Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.

The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Cheng-Kung University Hospital; National Taiwan University Hospital
• Treatments: Fluorouracil; Gemcitabine; Leucovorin; Oxaliplatin

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.