UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000138
Receipt number R000000205
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)
Date of disclosure of the study information 2005/09/08
Last modified on 2015/10/22 15:15:47

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Basic information

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

Condition

gastric neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

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


Assessment

Primary outcomes

overall survival

Key secondary outcomes

adverse events


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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



Public contact

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


Sponsor or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

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)


Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name