GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Detailed Description
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Pancreatic cancer is the fifth leading cause of cancer death in the United States. It is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. Patients with unresectable pancreatic cancer has a poor prognosis. Gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(MST) ranging from 6 to 8 months. Phase Ⅲ study showed that combinations with other drugs, such as oxaliplatine or CDDP, did not contribute to survival time. TS-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO), is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 was effective as a single agent for treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). A combination of gemcitabine and TS-1 is found to be effective and promising in phase Ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. This phase Ⅱ randomized controlled study compares efficacy and feasibility of GEM+S-1 with GEM alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Official Title
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Randomized Phase II Study of Gemcitabine (GEM) Versus GEM+TS-1 for Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine + S-1
* Drug: gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven unresectable pancreatic carcinoma There must be measurable lesions with multislice CT ECOG Performance status 0-2 No other active cancer No previous therapy such as radiotherapy, chemotherapy and immunotherapy Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min No serious complications Be able to eat food Life expectancy of more than 8 weeks duration Informed consent is obtained- Exclusion Criteria: Interstitial pneumonia Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months Serious infection Pregnant or lactating females History of serious drug allergy Serious other complications Uncontrolled mental disorders -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>gemcitabine + S-1 | Drug: gemcitabine + S-1<br>* gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks<br>* Other names: TS-1;|
| Active Comparator: 2<br>S-1 | Drug: gemcitabine<br>* gemcitabine DIV on day one , 8th and 15th<br>* Other names: gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | during observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median survival time(MST) |  | during observation | 
| time-to-progression(TTP) |  | from onset of regression to progression | 
| toxicity |  | during observation | 
| clinical benefit response |  | during observation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic carcinoma, gemcitabine, S-1, phaseⅡstudy