Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GS, GnP.
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP
Overview
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
- Drug GS
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. - Drug GnP
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.
Primary outcome measures
- overall survival [Time frame: 5 years]
Secondary outcome measures (1)
- adverse events [Time frame: up to 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Takehiro Okabayashi — Kochi
Identifiers
NCT: NCT05268692 · GSGnP