UMIN-CTR Clinical Trial

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

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chiba study group of adjuvant chemotherapy for pancreatic cancer

Institute

Department

Personal name

Organization

non

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

2011

Year

05

Month

10

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

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 related information

Registered date

2011

Year

05

Month

09

Day

Last modified on

2014

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006373