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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005708
Receipt No. R000006750
Scientific Title Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Date of disclosure of the study information 2011/06/02
Last modified on 2015/04/21

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Basic information
Public title Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Acronym Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)
Scientific Title Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
Scientific Title:Acronym Assessment of optimal dosage and biomarker in capecitabine plus fractional cisplatin as the first-line therapy in patients with advanced or recurrent gastric cancer.
(KOGC-05 Trial)
Region
Japan

Condition
Condition Patients with unresctable or recurrent gastric cancer.
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess maximum tolerated dose in order to determine recommended dose of capecitabine plus fractional cisplatin as the first-line therapy in patients with resectable or recurrent gastric cancer.
Furthermore, this exploratory study is also designed to evaluate predictable several factor levels in the resected tumor tissues and plasma from the registrated patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Incidence of dose limiting toxicity
Key secondary outcomes Overall Response rate
Exploring several predictable biomarkers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Capecitabine plus fractional cisplatin:

Level 1
Capecitabine:2,000mg/m2/day p.o.(day1-15)
Cisplatin:15mg/m2 i.v.
(day1, 8, 15)
to be repeated every 3 weeks.

Cisplatin is administered with an initial dose of 15mg/m2, stepped up to 20mg/m2 or 25mg/m2.
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
74 years-old >=
Gender Male and Female
Key inclusion criteria (1) Histological confirmation of gastric adenocarcinoma.
(2) Patients with an advanced or recurrent gastric cancer with estimative lesion, and had received no previous chemotherapy.
i) Patients with unresectable gastric cancer who had not received any intervention except surgical procedure.
ii) Patients with recurrent gastric cancer who had not been treated by any therapy against for the recurrent site.
(3) Patient who are possible to be orally administrated capecitabene.
(4) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1.
(5) 20 years old or more,and 74 years old or less when received informed consent.
(6) Written informed consent.
(7) Life expectancy estimate 3 months, and more.
(8) Vital organ functions (listed below) are preserved within 14 days prior to entry.
i) White blood cell count >= 4,000/mm3
Neutrophils>=2,000/mm3
ii) Platelets>=100,000/mm3
iii).Hemoglobin>=9.0 g/dl
iv).Total bilirubin<=1.5 mg/dl
v). AST and ALT <= 100 I/U
vi). Serum albumin >= 2.5 g/dl
vii). Serum creatinine <= 1.2 mg/dl
or estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min
Key exclusion criteria (1) Patients who had previously received chemotherapy including a fluorouracil-based regimen at least 6 month before registration.
(2) Patients who had previously received chemotherapy including a Platinum-based regimen.
(3) Patients with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency.
(4) Patients who have history of active simultaneous or metachronous double cancers within 5 year.
However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.
(5) Patients With severe or uncontrolled complication (infection, pulmonary fibrosis, intestinal paralysis, intestinal obstruction, uncontrolled diabetes mellitus, liver cirrhosis, history of myocardial infarction within 6 month, unstable angina, and so on.)
(6) Patients with pericardial fluid or massive pleural or peritoneal fluid that required drainage.
(7) Patients with CNS metastases only.
(8) Patients with gastrointestinal bleeding which require a repeat blood transfusion.
(9) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication.
(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) Patients who have been treated with antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 2 weeks before registration by the physician decision (Except for low-dose of aspirin).
(13) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers.
(14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin.
(15) Patients who are inappropriate for the study at the physician's assessment
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-2681
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsunehiro Takahashi
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-2681
Homepage URL
Email

Sponsor
Institute Department of Surgery, School of Medicine, Keio University
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
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

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 02 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 Completed
Date of protocol fixation
2011 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 02 Day
Last modified on
2015 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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