Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

Detailed Description
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When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular. In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt. We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.

Official Title
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Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Drug: gemcitabine, S-1
* Drug: gemcitabine, S-1, radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below. Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.) Involving over the merging section of portal-SMV. No distal metastasis with diagnostic imaging. Confirmed by CT image performed with in four weeks before registration. Performance Status:0-1(ECOG) Patients of age =>20 and 80> sufficient organ functions neutrophils>=1,500/mm3 platelets>=100,000/mm3 hemoglobin>=9.0g/dl AST(GOT)/ALT(GPT) <=150IU total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present) serum creatinine <= 1.2mg/dl creatinine clearance>=60ml/min Life expectancy more than 3 months. Written informed consent. Exclusion Criteria: Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. Watery diarrhea Severe infection Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) Massive pleural or abdominal effusion. Metastasis to central nervous system. Active synchronous or metachronous malignancy other than carcinoma in situ. Regular use of flucytosine, fenitoin or warfarin Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy Severe mental illness Patients who are judged inappropriate for the entry into the study by the investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: Gemcitabine , S-1<br>Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks | Drug: Drug: gemcitabine, S-1<br>* Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.<br>* Other names: TS-1;|
| Experimental: Gemcitabine, S-1, radiotherapy<br>Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions | Drug: gemcitabine, S-1, radiotherapy<br>* Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.<br>* Other names: TS-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two year survival rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival（PFS） |  | 4 years | 
| Overall Survival (OS) |  | 4 years | 
| Adverse events |  | 4 years | 
| Response rate |  | 4 years |