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 |
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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
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
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
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
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
