Trial of the effectiveness of nutritional intervention for patients who are administered TS-1 after surgical resection of pancreatic cancer (Elental adjuvant S-1 trial)

Completed

• Conditions: pancreatic cancer

• Registration Number: jRCT1051180068

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-23
• Study First Submitted: 2019-02-19
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Eligebility Criteria during hospital state
1)patients 20 years old or more
2)proven pancreatic cancer histlogecally
3)confirmed by R0 or R1 surgery
4)PS (ECOG) between 0 and 2
5)wityout any prior chemotherapy and/or radiation therapy
6)with good oral intake
7)written informed consent to participate in this study
8)without any severe diseases and with a good condition of important organs for administration of TS-1
a)WBC >= 2,500/mm3
b)neutrophil >= 1,200/mm3
c)platelet >=75,000/mm3
d)hemoglobin >= 8.0g/L
e)total bilirubin <= 1.5mg/dL f)AST/ALT <= 100 IU/L
g)Creatinin clearance >= 40ml/min
CC by Cockcroft-Gault method is avilable

Exclusion Criteria

Exclusion Criteria during hospital stay
1)with active double cancer (*)
*Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
Cancers removed by EMR/ESD are included.
2)with a history of allergy against TS-1 and/or Elental
3)with active infection diseases
4)with uncontrollable hypertension
5)with uncontrollable DM
6)with severe heart diseases clinically
7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema)
8)with psychologic diseases and/or psychological symptpms
9)women pregnant and/or nursing or women who like to be pregnant
10)patient registered to the other study whose endpoints are same to This study.
11)patients whom doctor decide not to register to this study

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		the completion rate of S-1 adjuvant chemotherapy

Secondary Outcome Measures

Name	Time	Method
Nutrition Indicator		Body weight, BMI, s-Albumin, s-Protein, s-Cholesterol
RP of TS-1		on 4 courses