Pancreatic Adenocarcinoma
Conditions
Keywords
Neoadjuvant
Brief summary
The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.
Detailed description
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel
Interventions
DRUGGS
drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (\< 1.25 m2, 60 mg/d; ≥ 1.25 to \< 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle.
DRUGGnP
drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
Sponsors
Kochi University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
elective pancreatectomy for pancreatic cancer
Exclusion criteria
a previous cancer surgery a body weight loss of \>10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | postoperative survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | up to 24 weeks | incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer |
Countries
Japan
Outcome results
None listed