UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010949
Receipt number R000012788
Scientific Title Randomized phase II/III study of 5-fluorouracil /l-leucovorin vs. 5-fluorouracil /l-leucovorin plus paclitaxel in gastric cancer with severe peritoneal metastasis (JCOG1108/WJOG7312G, abbreviation:GC_FL/FLTAX_P2/3)
Date of disclosure of the study information 2013/06/13
Last modified on 2018/01/30 14:54:36

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Basic information

Public title

Randomized phase II/III study of 5-fluorouracil /l-leucovorin vs. 5-fluorouracil /l-leucovorin plus paclitaxel in gastric cancer with severe peritoneal metastasis (JCOG1108/WJOG7312G, abbreviation:GC_FL/FLTAX_P2/3)

Acronym

Phase II/III study of 5-FU/l-LV vs. 5-FU/l-LV+PTX in gastric cancer with severe peritoneal metastasis (FL/FLTAX trial)

Scientific Title

Randomized phase II/III study of 5-fluorouracil /l-leucovorin vs. 5-fluorouracil /l-leucovorin plus paclitaxel in gastric cancer with severe peritoneal metastasis (JCOG1108/WJOG7312G, abbreviation:GC_FL/FLTAX_P2/3)

Scientific Title:Acronym

Phase II/III study of 5-FU/l-LV vs. 5-FU/l-LV+PTX in gastric cancer with severe peritoneal metastasis (FL/FLTAX trial)

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Medicine in general Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of 5-fluorouracil /l-leucovorin plus paclitaxel (FLTAX) in gastric cancer with severe peritoneal metastasis in a randomized phase II/III study comparing 5-fluorouracil /l-leucovorin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

Phase II: Median survival time in both arms and proportion of treatment continuation at 8th week in FLTAX arm

Phase III: Overall survival

Key secondary outcomes

Phase II: Proportion of treatment continuation at 8th week in 5-FU/l-LV arm and adverse events in both arms

Phase III: Adverse events, Proportion of oral intake improvement, Ascites drainage-free survival, Proportion of ascites response, Proportion of ascites control, QOL, Time-to-treatment failure, Dose intensity


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: 5-FU/ l-LV

5-FU : 600 mg/m2/day, bolus (1 hour after start of l-LV) : day 1, 8, 15, 22, 29, 36
l-LV : 250 mg/m2/day, div (2 hours) : day 1, 8, 15, 22, 29, 36
q8w

Interventions/Control_2

B: FLTAX

5-FU : 500 mg/m2/day, bolus (1 hour after start of l-LV) : day 1, 8, 15
l-LV : 250 mg/m2/day, div (2 hours) : day 1, 8, 15
PTX : 60 mg/m2/day, div (1 hours) : day 1, 8, 15
q4w

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) Unresectable or recurrent gastric cancer with peritoneal metastasis
2) histologically confirmed adenocarcinoma
3) Massive ascites and/or inadequate oral intake. In case of massive ascites and inadequate oral intake, patients with PS0 or PS1 are eligible.
4) No metastasis to central nervous system
5) No fistula between tumor and other organ
6) No pleural effusion needed to be removed
7) Measurable or non-measurable disease
8) Between the ages of 25 and 75
9) ECOG Performance status(PS): 0, 1, 2. In case of patients with PS2, massive ascites, and inadequate oral intake, they are ineligible.
10) HER2 untested or negative in case of tested
11) No previous chemotherapy or radiotherapy or chemoradiotherapy or hormone therapy for other malignancies (neoadjuvant or adjuvant chemotherapy for gastric cancer is allowed as long as it was completed at least 24 weeks prior to randomization)
12) Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
<1> Neutrophil count: 1,500/mm3 or above
<2> Hemoglobin: 8.0 g/dL or above
<3> Platelet count: 100,000/mm3 or above
<4> Total bilirubin: 1.5 mg/dL or less
<5> AST (GOT) :100 IU/L or less
<6> ALT (GPT) :100 IU/L or less
<7> Serum creatinin: 2.0 mg/dL or less
13) Written infromed consent

Key exclusion criteria

1) Other currently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in -situ deemed cured by adequate treatment
2) Active infection
3) Body temperature >= 38 degrees Celsius
4) Pregnant of lactating female
5) Psychiatric disease that is inappropriate for entry into this study
6) Continuous systemic steroids
7) Uncontrolled diabetes despite routine administration of insullin
8) Myocardial infarction within the last 6 months, unstable angina pectoris within the last 3 weeks
9) History of any medical condition including renal insufficiency, liver insufficiency, and interstitial pneumonitis
10)Active bleeding
11) HBs Ag: positive, HCV Ab: positive

Target sample size

330


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name JCOG: Narikazu Boku, WJOG: Takako Nakajima

Organization

JCOG: National Cancer Center Hospital / WJOG: St.Marianna University School of Medicine

Division name

JCOG:Department of Gastrointestinal Medical Oncology / WJOG: Department of Clinical Oncology

Zip code


Address

JCOG: 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN / WJOG: 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan

TEL

(03)-3542-2511(044)-977-8111

Email

tnakajima@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kensei Yamaguchi, Takako Nakajima

Organization

JCOG1108/WJOG7312G Coordinating Office

Division name

The Cancer Institute Hospital Of JFCR / St.Marianna University School of Medicine

Zip code


Address

3-8-31, Ariake, Koto, Tokyo 135-8550, Japan / 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511,

TEL

(044)-977-8111(03)-3520-0111

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

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

West Japan Oncology Group (WJOG)

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

KKR札幌医療センター 斗南病院(北海道)
函館厚生院函館五稜郭病院(北海道)
恵佑会札幌病院(北海道)
市立室蘭総合病院(北海道)
岩手医科大学(岩手県)
国立病院機構仙台医療センター(宮城県)
宮城県立がんセンター(宮城県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
筑波大学附属病院(茨城県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
龍ケ崎済生会病院(茨城県)
自治医科大学附属病院(栃木県)
栃木県立がんセンター(栃木県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
東京女子医科大学 八千代医療センター(千葉県)
杏林大学医学部付属病院(東京都)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京医科歯科大学(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
都立墨東病院(東京都)
慶應義塾大学病院(東京都)
帝京大学医学部附属病院(東京都)
東京都済生会中央病院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
北里大学医学部(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)
聖マリアンナ医科大学病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
富山県立中央病院(富山県)
富山大学附属病院(富山県)
厚生連高岡病院(富山県)
石川県立中央病院(石川県)
佐久総合病院佐久医療センター(長野県)
岐阜大学医学部(岐阜県)
岐阜市民病院(岐阜県)
静岡県立総合病院(静岡県)
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)
名古屋大学医学部(愛知県)
名古屋市立大学病院(愛知県)
名古屋第一赤十字病院(愛知県)
京都第2赤十字病院(京都府)
国立病院機構京都医療センター(京都府)
京都市立病院(京都府)
大阪労災病院(大阪府)
大阪大学医学部(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪医科大学(大阪府)
市立豊中病院(大阪府)
市立堺病院(大阪府)
関西医科大学附属枚方病院(大阪府)
大阪市立総合医療センター(大阪府)
神戸大学医学部(兵庫県)
関西労災病院(兵庫県)
兵庫医科大学(兵庫県)
兵庫県立がんセンター(兵庫県)
市立伊丹病院(兵庫県)
医療法人薫風会 佐野病院(兵庫県)
天理よろづ相談所病院(奈良県)
近畿大学医学部奈良病院(奈良県)
土庫病院(奈良県)
和歌山県立医科大学(和歌山県)
島根大学医学部(島根県)
独立行政法人国立病院機構 岡山医療センター(岡山県)
岡山大学病院(岡山県)
津山中央病院(岡山県)
川崎医科大学附属病院(岡山県)
広島大学病院(広島県)
広島市立広島市民病院(広島県)
広島市立安佐市民病院(広島県)
福山市民病院(広島県)
県立広島病院(広島県)
徳島赤十字病院(徳島県)
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)
九州病院(福岡県)
独立行政法人国立病院機構 九州がんセンター(福岡県)
九州大学病院(福岡県)
佐賀大学医学部附属病院(佐賀県)
熊本大学医学部附属病院(熊本県)
大分大学医学部附属病院(大分県)
宮崎大学医学部附属病院(宮崎県)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2013 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 13 Day

Last follow-up date

2018 Year 03 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is conducted as intergroup study of Japan Clinical Oncology Group(JCOG) and West Japan Oncology Group(WJOG).


Management information

Registered date

2013 Year 06 Month 13 Day

Last modified on

2018 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name