Pancreatic Cancer
Conditions
Keywords
locally advanced
Brief summary
This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
Detailed description
The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
Interventions
DRUGgemcitabine, cisplatin, capecitabine
Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* unresectable locally advanced pancreatic cancer * no distant metastasis * histologically confirmed adenocarcinoma of pancreas * 18-75 of age * ECOG performance status 0-2 * normal marrow function : * WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * normal liver function : --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN) * normal renal function : --Creatinine no greater than 1.5 times ULN * signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 1 year | response rate by RECIST criteria |
| overall survival | 1 year | — |
| clinical benefit rate | 1 year | CR+PR+SD by RECIST criteria |
| safety | 12 months | number of patients who experienced grade 3-4 toxicity by NCI-CTCAE |
| 1 year survival rate | 1 year | — |
Countries
South Korea
Outcome results
None listed