Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Multiple centers, uncontrolled, open-label, non-randomized single-arm study

Detailed Description
-----------------
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer

Official Title
-----------------
Phase II Trial of Biweekly S-1, Leucovorin and Gemcitabine in Elderly Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: chemotherapy: TS-1, Leucovorin and Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. Baseline ECOG performance status is 2. Patients have life expectancy of at least 12 weeks. Patients have age 70 years. Patients have adequate organ function. Patients with biliary obstruction which is adequate drained before enrollment are eligible. Patients agree to have an indwelling venous catheter implanted. Women or men of reproductive potential should agree to use an effective contraceptive method. All patients must be informed of the investigational nature of this study and must sign written informed consents. Exclusion Criteria: Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease. Patients with metastatic lesion in central nervous system. Patients with active infection. Patients with active cardiopulmonary disease or history of ischemic heart disease. Patients who have peripheral neuropathy > grade I of any etiology. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biweekly TS-1, Leucovorin and Gemcitabine (GSL)<br>Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle | Drug: chemotherapy: TS-1, Leucovorin and Gemcitabine<br>* Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | The progression-free survival time for elderly patients with advanced pancreatic cancer | up to 5.0 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tumor response rate |  | up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
in Elderly Patients