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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009822
Receipt No. R000011504
Scientific Title Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer
Date of disclosure of the study information 2013/01/20
Last modified on 2014/11/04

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Basic information
Public title Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer
Acronym Randomized phase II trial of GS neoadjuvant therapy for patients with resectable pancreatic cancer (CAP-004)
Scientific Title Randomized phase II trial of neoadjuvant Chemotherapy with Gemcitabine and S-1 vs. without neoadjuvant chemotherapy in patients with resectable pancreatic cancer
Scientific Title:Acronym Randomized phase II trial of GS neoadjuvant therapy for patients with resectable pancreatic cancer (CAP-004)
Region
Japan

Condition
Condition Resectable pancreatic cancer
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy and feasibility of gemcitabine and S-1 combination therapy as neoadjuvant chemotherapy for resectable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Two year disease progression free survival rate
Key secondary outcomes overall survival, disease free survival, R0 resection rate, R0+1 resection rate, histological efficacy of chemotherapy, Adverse events, recurrent location, tumor marker level, relative intensity, surgical complication rate, responce rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine and S-1 combination neoadjuvant chemotherapy (GS group):
S-1 60mg/m2/day for 14days and gemcitabine 1000mg/m2 at day8 and 15 within 21days as 1 course.
total 3 courses followed by surgical resection.
After operation, patients are treated with S-1 (80mg/m2/day X 14days in 21days course X 8 courses) as adjuvant therapy
Interventions/Control_2 Surgery group:
Surgical resection followed by S-1 therapy (80mg/m2/day X 14days in 21days course X 8 courses) as adjuvant therapy
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) Resectable pancreatic cancer in preoperative imaging diagnosis
2) Pancreatic cancer without distant metastasis
3) Imaging diagnosis shows following criteria
a. Without abutment to major arteries such as SMA, HA and CEA
b. Portal vein or SMV stenosis within 50% in diameter
4) Performance Status 0 or 1
5) Adequate hematologic, renal and hepatologic function
6) Provided written informed consent.
Key exclusion criteria 1. Inadequate physical condition for gemcitabine or S-1 treatmetn according to manufacture's instruction
2. Sever myelosuppression
3. Pregnancy, breast feeding, or women who desire to preserve fecundity
4. Sever renal dysfunction
5. Sever hepatic dysfunction
6. With other anticancer treatment
7. With flucitocine or warfarin potassium treatment
8. With pulmonary fibrosis
9. With history of radiation to lung field
10. Active infectious disease
11. Massive pleural effusion
12. With distant metastasis
13. Active malignancies other than pancreatic cancer
14. Severe angina, cardiac infurction within 3 months at the registration, and severe hear failure
15. Severe diabetes or hypertension
16. Severe mental disorder
17. Inadequate physical condition, as diagnosed by primary physician
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miyazaki
Organization Chiba unviersity, Graduate School of Medicine
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, JAPAN
TEL 81-43-222-7171
Email masaru@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Yoshitomi
Organization Chiba unviersity, Graduate School of Medicine
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, JAPAN
TEL 81-43-222-7171
Homepage URL
Email yoshitomi@faculty.chiba-u.jp

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

Funding Source
Organization none
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
2013 Year 01 Month 20 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 20 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
2013 Year 01 Month 20 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011504

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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