UMIN-CTR Clinical Trial

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

Resectable pancreatic cancer

Classification by specialty

Surgery in general	Hepato-biliary-pancreatic surgery	Adult

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Chiba study group of adjuvant chemotherapy for pancreatic cancer

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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