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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN 000012254 | Registry Identifier | UMIN |
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The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.
Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Nab-Paclitaxel | Experimental | A conformal phase I study using 3 plus 3 method. Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered. Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm. Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 1 years | |
| Overall Survival time | 2 years |
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Inclusion Criteria:
Histologically or cytologically confirmed advanced pancreatic cancer
Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
Performance Status:0-1(ECOG)
Patients of age =>20 and 75>
White Blood Cell (WBC) >=3,500/mm3,12,000/mm3,
Life expectancy more than 3 months.
Written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatsuya Ioka, MD | Osaka Medical Center for Cancer and Cardiovascular Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka | 537-8511 | Japan |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Nab-Paclitaxel | Drug | Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |