UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000012491
Receipt number	R000014619
Scientific Title	Phase II study of a utility and the biomarker of the capecitabine plus cisplatin chemotherapy for the HER2-negative gastric cancer which is impossible of curative resection
Date of disclosure of the study information	2013/12/05
Last modified on	2021/08/14 16:44:18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Phase II study of a utility and the biomarker of the capecitabine plus cisplatin chemotherapy for the HER2-negative gastric cancer which is impossible of curative resection

Acronym

ReStage study

Scientific Title

Phase II study of a utility and the biomarker of the capecitabine plus cisplatin chemotherapy for the HER2-negative gastric cancer which is impossible of curative resection

Scientific Title:Acronym

ReStage study

Region

Japan

Condition

Advanced gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To analysis the effective of Capecitabine plus Cisplatin treatment and association of the biomarker

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Assessment

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Progression free survival
Adverse event rate
Exploring several predictable biomarkers

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Patient who is pathologically confirmed as HER2 negative adenocarcionoma
(2)Patient with gastric cancer of progress or recurrence that is unresectable by initial treatment
(3) Measurable lesion is confirmed by CT or MRI before registration within 28 days
(4)Patient who has not received any therapy including radiotherapy and chemotherapy except the case that passed as postoperative adjuvant chemotherapy more than 6 months
(5) Patient who are possible to be orally administration Capecitabine
(6) PS (ECOG) is 0-1
(7) Age from 20 years
(8) Written informed consent
(9) Life expectancy of more than 3 months
(10) Adequate organ function (Neutrophil counts >= 2000/mm3 , Platelets >= 100000/mm3, Hemoglobin >= 9.0g/dL, T-bil <1.5 mg dL, AST,ALT <2.5 x upper normal limit(If a patient have liver metastasis, AST and ALT less than 5 times the upper limit of normal) , Serum creatinine <= 1.2mg/dl, Creatinine clearance >= 60ml/min

Key exclusion criteria

(1) Patient who had previously received chemotherapy including a fluorouracil based regimen at least 6 months before registration
(2) Patient who had previously received chemotherapy including a Platinum based regimen
(3) Patient with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency
(4) Active concomitant malignancy (History of active double cancer within 5 years prior to the study)
(5) Patient who has severe or uncontrolled complication (infection, pulmonary fibrosis, paralytic intestine, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, uncontrolled hypertension, myocardiac infarction or unstable angina within 6 months before registration)
(6) Patient who needs drainage of peritoneal, pleural or pericardial effusion
(7) With symptoms due to brain metastasis
(8) Active (significant or uncontrolled) bleeding from GI tract
(9) Uncontrollable serious mental problem
(10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy
(11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool) at registration
(12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low dose of aspirin)
(13) Women who is pregnancy, possible pregnancy or lactation and patients who wish their partner to become pregnant
(14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin.
(15) Any other patients whom the physician in charge of the study judges to be unsuitable

Target sample size

Research contact person

Name of lead principal investigator

1st name Hideaki

Middle name

Last name Shimada

Organization

Toho University school of Medicine

Division name

Division of General and Gastroenterological Surgery, Department of Surgery (Omori)

Zip code

143-8541

Address

6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Email

hideaki.shimada@med.toho-u.ac.jp

Public contact

Name of contact person

1st name Yoshinori

Middle name

Last name Kikuchi

Organization

Toho University

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine (Omori)

Zip code

143-8541

Address

6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan

TEL

03-3762-4151

Homepage URL

Email

ganpro-toho@med.toho-u.ac.jp

Sponsor or person

Institute

Department of Clinical Oncology, Toho University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Medical School Ethics Committee, Toho University

Address

5-21-16 Oomorinishi Oota-ku Tokyo

Tel

03-3762-4151

Email

med.rinri@ext.toho-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東邦大学医療センター大森病院

Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 05 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 10 Month 28 Day

Date of IRB

2013 Year 12 Month 05 Day

Anticipated trial start date

2013 Year 12 Month 05 Day

Last follow-up date

2017 Year 10 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Serum is extracted before medical treatment and after medical treatment, TYMP is measured, and relevance with a curative effect is observed.

Management information

Registered date

2013 Year 12 Month 04 Day

Last modified on

2021 Year 08 Month 14 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014619

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name