UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005578
Receipt No. R000006373
Scientific Title A phase II trial of Neoadjuvant and adjuvant chemotherapy with Gemcitabine and TS-1 combination for patients with locally advanced pancreatic cancer
Date of disclosure of the study information 2011/05/10
Last modified on 2014/11/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase II trial of Neoadjuvant and adjuvant chemotherapy with Gemcitabine and TS-1 combination for patients with locally advanced pancreatic cancer
Acronym CAP-003
Scientific Title A phase II trial of Neoadjuvant and adjuvant chemotherapy with Gemcitabine and TS-1 combination for patients with locally advanced pancreatic cancer
Scientific Title:Acronym CAP-003
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the effectiveness and safety of Neoadjuvant and adjuvant chemotherapy using the combination of gemcitabine and S-1 against initially borderline or unresectable locally advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes resection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, recurrence type, tumor marker, relative dose intensity, tumor response rate, surgical morbidity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1)Neoadjuvant chemotherapy: 3 course of gemcitabine and s-1 combination therapy (21days for one course:day1-14 S-1 60mg/m2, day8 and 15 gemcitabine 1g/m2)
2)Surgical resection
3)Adjuvant therapy: 8 course of gemcitabine and s-1 combination therapy (21days for one course:day1-14 S-1 50mg/m2, day8 and 15 gemcitabine 0.8g/m2)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Invasive ductal carcinoma or invasive intraductal papillary-mucinors carcinoma proved by Radiological examination (enhanced CT or MRI)
2)No distant metastasis
3)Borderline or unresectable locally advanced pancreatic cancer
tumor abutment of the SMA, HA, CEA
tumor involving PV or SMV (diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter.

4)patients who can tolerate the pancreatic surgery.
5)Age 20 or more
6)No history of primary chemo therapy and/or radiation therapy.
7)ECOG performance status 0-1
8)Adequate organ function
9)Without problems for oral medication
10) Written informed consent
Key exclusion criteria 1) History of sever allergic reaction with gemcitabine or s-1
2)Sever myelosuppression
3) Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies.
4)Serious renal dysfunction
5)Serious liver dysfunction
6)Patients under treatment with other furuorouracil related chemotherapy
7)Patients under treatment with flucytosine.
8)Pulmonary fibrosis or interstitial pneumonia
9)History of breast or lung radiation
10)Active infection
11)Patients with pleural effusion
12)Evidence of distant metastasis
13)Active double cancer
14)Uncontrolled heart diseases such as angina, myocardial infarction within three months, and cardiac dysfunction
15)Uncontrolled diabetes or hypertension
16)Sever mental disorder
17)Inadequate physical condition, as diagnosed by primary physician
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miyazaki
Organization Chiba University, Graduate School of Medicine, Chiba Japan
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL 043-222-7171
Email masaru@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Yoshitomi
Organization Chiba University, Graduate School of Medicine, Chiba Japan
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL 043-222-7171
Homepage URL
Email yoshitomi@faculty.chiba-u.jp

Sponsor
Institute Chiba study group of adjuvant chemotherapy for pancreatic cancer
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 09 Day
Last modified on
2014 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006373

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.