UMIN-CTR Clinical Trial

Public title

Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Acronym

Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Scientific Title

Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Scientific Title:Acronym

Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer

Region

Japan

Condition

Advanced or recurrent gastric cancer previously treated with S-1

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate clinical usefulness of combination chemotherapy with weekly paclitaxel and 5'-DFUR in S-1 failure advanced or recurrent gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect, QOL

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

The treatment included PTX 70 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks and 5'-DFUR 600 mg/body p.o. everyday

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) Histologically proven unresectable or recurrent gastric cancer showing resistance to S-1.
2) ECOG Performance status:0-2
3) Up to one prior chemotherapy
4) 4 weeks rest after prior chemotherapy
5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
6) Adequate organ functions:
i) hemoglobin >=9.0g/dL,
ii) WBC >=4000/mm3,
iii) neutrophils >=2000/mm3,
iv) platelets >=100,000/mm3,
v) AST(GOT)/ALT(GPT) <=2.5 X UL,
vi) total bilirubin <=1.5mg/dL,
vii) creatinine <=1.5mg/dL,
7) Life expectancy of more than 3 months
8) Age greater than 20
9) Informed consent approved by IRB

Key exclusion criteria

1) Drug hypersensitivity.
2) Infection and inflammation.
3) Prior infusion of paclitaxel
4) Peripheral neuropathy
5) Active synchronous malignancy.
6) Brain metastasis.
7) Severe mental disorders.
8) Symptomatic pulmonary fibrosis or interstitial pneumonia.
9) Severe systemic edema.
10) A large amount of pleural effusion or peritoneal fluid.
11) Severe heart disease.
12) Myocardial infarction within six months.
13) DM with insulin injection.
14) Pregnant patient

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Masaaki Oka

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Email

sigefumi@yamaguchi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigefumi Yoshino

Organization

Yamaguchi University Graduate School of Medicine

Division name

Department of Digestive Surgery and Surgical Oncology

Zip code

Address

1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan

TEL

0836-22-2264

Homepage URL

Email

sigefumi@yamaguchi-u.ac.jp

Institute

Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

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

2012

Year

08

Month

06

Day

URL releasing protocol

Publication of results

Partially published

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

Open public recruiting

Date of protocol fixation

2007

Year

09

Month

20

Day

Date of IRB

Anticipated trial start date

2007

Year

10

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

2012

Year

08

Month

06

Day

Last modified on

2013

Year

09

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010143