Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine (Xeloda®) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | two year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae Hyun Kim | Contact | 82-31-920-0155 | krog@ncc.re.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Korea | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 24, 2014 | |
| Reset | Sep 30, 2014 | |
| Release | Oct 5, 2016 | |
| Reset | Nov 25, 2016 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 24, 2014 | Sep 30, 2014 | |||
| Oct 5, 2016 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D007103 | Immobilization |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Localization, simulation and immobilization | Radiation | Radiation dose and planning
|
|
| Nov 25, 2016 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D008919 | Investigative Techniques |