UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009822
Receipt number 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 22:46:28

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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 or person

Institute

Chiba study group of adjuvant chemotherapy for pancreatic cancer

Institute

Department

Personal name



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

Value
https://center6.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