S-1 And And Gemcitabine Vs Gemcitabine Alone As Adjuvant Chemotherapy For Patients With Resected Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-02-26
First Submitted that Met QC Criteria 2014-05-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-03-02
First Posted (ACTUAL) 2014-05-06	Results First Posted N/A	Last Verified 2022-02

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Gemcitabine Gemcitabine：1000mg/m2，iv 30min，d1, d8,d15 q4w, 6 cycles	DRUG: S-1, Gemcitabine
EXPERIMENTAL: S-1+ Gemcitabine S-1：40~60mg bid，d1~14; (S-1 dosage：BSA <1.25m2，40mg bid，1.25m2≤BSA≤1.5m2，50mg bid，BSA>1.5m2， 60mg bid) Gemcitabine：1000mg/m2，iv 30min，d1, d8 q3w, 8 cycles	DRUG: S-1, Gemcitabine

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Gemcitabine

Gemcitabine：1000mg/m2，iv 30min，d1, d8,d15 q4w, 6 cycles

DRUG: S-1, Gemcitabine

EXPERIMENTAL: S-1+ Gemcitabine

S-1：40~60mg bid，d1~14; (S-1 dosage：BSA <1.25m2，40mg bid，1.25m2≤BSA≤1.5m2，50mg bid，BSA>1.5m2， 60mg bid) Gemcitabine：1000mg/m2，iv 30min，d1, d8 q3w, 8 cycles

DRUG: S-1, Gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
DFS	Disease free survival	3 years

Secondary Outcome Measures	Measure Description	Time Frame
OS	Overall survival	5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute neutrophil count ≥1500 cell/mm3
Platelet count ≥100,000/mm3
Hemoglobin (Hgb) ≥9 g/dL 7. Acceptable blood chemistry levels:
Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT) and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
Total bilirubin ≤ Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
Alkaline phosphatase ≤ 2.5 x ULN
Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead 8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization 9. Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within normal limits (±15%)

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

PatientS

Caregivers

Clinical Trial Record