Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma

Study Overview
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Brief Summary
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The only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.

Official Title
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A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Capecitabine (Xeloda®)
* Radiation: Localization, simulation and immobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: There is no evidence of metastatic disease in the major viscera and no peritoneal seeding Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation All malignant disease must be encompassable within a single irradiation field (15x15cm maximum) All patients must have radiographically assessable disease No previous irradiation to the planned field Age of ≥18 years performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score Required Entry Laboratory Parameters WBC count ≥ 2,000/mm3;(ANC>1,000), hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreas ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained. Exclusion Criteria: There is evidence of metastasis in the major viscera or peritoneal seeding. Age of <18 years Previous history of RT adjacent to planned field poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score pregnant or breast feeding status previous history of uncontrolled other malignancies within 2 years

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Primary objectives : To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma Secondary objectives : To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate. | Drug: Capecitabine (Xeloda®)<br>* Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).<br>Radiation: Localization, simulation and immobilization<br>* Radiation dose and planning Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | two year |