UMIN-CTR Clinical Trial

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
Condition	Advanced gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

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	70

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
Institute	Department of Clinical Oncology, Toho University Graduate School of Medicine
Institute
Department

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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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	No longer recruiting
Date of protocol fixation	2013 Year 10 Month 28 Day
Date of IRB
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	2019 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.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

Contact us.