UMIN-CTR Clinical Trial

Unique ID issued by UMIN	C000000067
Receipt number	R000000110
Scientific Title	Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)
Date of disclosure of the study information	2005/08/18
Last modified on	2014/02/21 13:58:38

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Basic information

Public title

Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)

Acronym

Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)

Scientific Title

Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)

Scientific Title:Acronym

Randomized trial of adjuvant chemotherapy with cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer (JCOG9206-2)

Region

Japan

Condition

gastric neoplasm

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Relapse-free survival, the site of recurrence

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Surgery (Gastrectomy with D2 or greater lymph node dissection)

Interventions/Control_2

Surgery + chemotherapy

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

Not applicable

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Curative operation with D2 or greater lymph node dissection
(2) Histologically proven gastric adenocarcinoma
(3) Macroscopically serosa-positive (T3-4)
(4) No metastases to level 3 - 4 lymph nodes station (N0-2)
(5) 75 years or younger
(6) Negative peritoneal lavage cytology
(7) Adequate organ function
WBC >=4000/mm3, Hb >=11.0g/dl, Plt >=100.000/mm3, AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit, Creatinine clearance <=70 ml/min
(8) Written informed consent

Key exclusion criteria

(1) Prior chemotherapy or radiotherapy
(2) Synchronous or metachronous malignancy in other organs

Target sample size

280

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hiroshi Furukawa, MD, PhD

Organization

Sakai Municipal Hospital

Division name

Surgery

Zip code

Address

1-1-1 Minamiyasui-cho, Sakai, Osaka 590-0064, JAPAN

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name Mitsuru Sasako, MD, PhD

Organization

JCOG9206-2 Coordinating Office

Division name

Gastric Surgery Division, National Cancer Center Hospital

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 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

YES

Study ID_1

NCT00147147

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 18 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/21336855

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

1992 Year 12 Month 09 Day

Date of IRB

Anticipated trial start date

1993 Year 01 Month 01 Day

Last follow-up date

2004 Year 03 Month 01 Day

Date of closure to data entry

2004 Year 12 Month 01 Day

Date trial data considered complete

2004 Year 12 Month 01 Day

Date analysis concluded

2005 Year 01 Month 01 Day

Other

Other related information

Management information

Registered date

2005 Year 08 Month 18 Day

Last modified on

2014 Year 02 Month 21 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000110

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

1st name
Middle name
Last name	Hiroshi Furukawa, MD, PhD