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Investigator decided to stop the study because it was difficult to proceed with the study.
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Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40% of pancreatic cancer patients were diagnosed as locally advanced unresectable status without distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality for locally advanced pancreatic cancer. However, several adverse events of chemoradiation could lead unfavorable treatment results, which included unique gastrointestinal (GI) toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the radiation field. According to the study in the investigators hospital, 45% of locally advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among them, 65% of the patients experienced the significant hemorrhage events. Although these GI toxicities, the studies for radioprotective agents were limited. AlbisĀ® is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the radioprotective effect of AlbisĀ® for locally advanced pancreatic cancer patients treated with CCRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlbisĀ® | Experimental | The intervention group |
|
| Placebo | Placebo Comparator | The placebo comparator group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlbisĀ® | Drug | The patients take AlbisĀ® 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after radiation, they receive the 1 month's medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal ulcer incidence | After 1 month after the chemoradiation, all the patients receive the esophagogastroduodenoscopy to detect the development of gastrointestinal ulcers. The proportion of patients with radiation-induced GI ulcers in each group will be investigated | within 4 weeks from end of chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event of gastrointestinal hemorrhage | within 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Placebo | Drug | The patients take placebo 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after radiation, they receive the 1 month's medication. |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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