UMIN-CTR Clinical Trial

Public title

Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Acronym

Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Scientific Title

Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Scientific Title:Acronym

Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

Region

Japan

Condition

gastric neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate safety and efficacy of low-dose paclitaxel as a second-line treatment for recurrence or unresectable gastric cancer patients with peritoneal metastasis who is refractory to fluoropyrimidine analogs containing regimen in comparison with best available 5-FU.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

overall survival

Key secondary outcomes

adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: Best available 5-FU
In the best available 5-FU arm, 5-FU continuous infusion (5-FUci) regimen or sequential methotrexate (MTX) and 5-fluorouracil (MTX/5-FU) regimen is selected according to patients' prior chemotherapy: If the prior chemotherapy included 5-FU bolus infusion or MTX, 5-FUci regimen will be selected. The other cases select MTX/5-FU regimen.
The 5-FUci regimen consists of 5-FUci (800 mg/m2/day, days 1 through 5), every 4 weeks. The MTX/5-FU regimen consists of MTX bolus infusion (100 mg/m2/day, day 1), 5-FU bolus infusion (600 mg/m2/day, day 1) after MTX, and l-leucovorin administration by oral or infusion (10 mg/m2/6 hour, days 2 through 3), which are repeated weekly.

Interventions/Control_2

B: Low dose paclitaxel
The low-dose paclitaxel regimen consists of 1-hour paclitaxel infusion (80 mg/m2/day, days 1, 8, and 15) every 4 weeks.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) they have histologically proven recurrence or unresectable gastric adenocarcionoma
(2) they have peritoneal metastasis
(3) they have no symptomatic central nerve system metastasis
(4) they are aged 20-75 years
(5) they have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
(6) In recurred cases, they had received fluoropirimidine analogs containing regimen as adjuvant chemotherapy. The period from last administration of adjuvant chemotherapy should be within 24 days. In unresectable cases, they had received fluoropirimidine analogs containing regimen as 1st line chemotherapy. The period from last administration of 1st line chemotherapy should be within 6 weeks. The fluoropirimidine analogs containing regimen is as follows: fluorouracil (5-FU), uracil and tegafur (UFT), tegafur, gimeracil, oteracil potassium (TS-1), 1-hexylcarbamoyl-5-fluorouracil (HCFJ), tegafur, 5'-DFUR;doxifluridine (FT)
(7) their prior chemotherapy did not include taxanes nor bolus infusion and continuous infusion of 5-FU (i.e., FOLFOX, FOLFILI, FAMTX, or ECF)
(8) they have sufficient organ function
(9) they have no history of gastrointestinal surgery
(10) they have no history of chemotherapy except for gastric cancer
(11) they have no history of radiotherapy for any malignancy
(12) they provided written informed consent

Key exclusion criteria

(1) diabetes mellitus, uncontrolled or controlled with insulin
(2) unstable angina, or myocardial infarction within 6 months prior to the study
(3) arrhythmia, needing medical intervention
(4) hypersensitivity to alcohol
(5) HBs antigen or their HCV antibody are positive
(6) massive pleural effusion
(7) Grade 3-4 diarrhea (CTCAE ver3.0)
(8) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(9) pregnant or lactating women
(10) severe mental disease
(11) not appropriate for the trial at the physician's assessment

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hiroya Takiuchi, MD, PhD

Organization

Osaka Medical College

Division name

Second Department of Internal Medicine

Zip code

Address

2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hiroya Takiuchi, MD, PhD

Organization

JCOG0407 coordinating Office

Division name

Second Department of Internal Medicine,Osaka Medical College

Zip code

Address

2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

北海道大学病院（北海道）
斗南病院（北海道）
岩手県立中央病院（岩手県）
東北大学病院（宮城県）
山形県立中央病院（山形県）
茨城県立中央病院・茨城県地域がんセンター（茨城県）
栃木県立がんセンター（栃木県）
自治医科大学（栃木県）
埼玉県立がんセンター（埼玉県）
国立がんセンター東病院（千葉県）
千葉県がんセンター（千葉県）
総合病院国保旭中央病院（千葉県）
国立がんセンター中央病院（東京都）
昭和大学病院（東京都）
癌研究会有明病院（東京都）
北里大学東病院（神奈川県）
神奈川県立がんセンター（神奈川県）
横浜市立市民病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
佐久総合病院（長野県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）
愛知県がんセンター愛知病院（愛知県）
京都大学医学部附属病院（京都府）
大阪市立総合医療センター（大阪府）
大阪医科大学（大阪府）
神戸大学医学部（兵庫県）
兵庫県立がんセンター（兵庫県）
国立病院機構四国がんセンター（愛媛県）
高知医療センター（高知県）

Date of disclosure of the study information

2005

Year

09

Month

08

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26386560

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Completed

Date of protocol fixation

2005

Year

06

Month

29

Day

Date of IRB

Anticipated trial start date

2005

Year

09

Month

01

Day

Last follow-up date

2010

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2010

Year

04

Month

01

Day

Other related information

Registered date

2005

Year

09

Month

08

Day

Last modified on

2015

Year

10

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000205