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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004734
Receipt No. R000005633
Scientific Title Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Date of disclosure of the study information 2010/12/20
Last modified on 2015/04/21

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Basic information
Public title Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Acronym Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP
Scientific Title Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Scientific Title:Acronym Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP
Region
Japan

Condition
Condition Stage III gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Primary objective is to estimate the maximum tolerated dose (MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes estimate the maximum tolerated dose(MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP
Key secondary outcomes Adverse events

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 At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest. At the second course, S-1 with CDDP adjuvant chemotherapy is conducted. S-1 is orally administered for 28 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) confirmed gastric cancer by endscopic biopsy
2) >=D2 lymph node dissection, R0 resection
3) Stage III
4) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology
5) age: >=20 and <80
6) possible to oral intake
7) No prior treatment except to surgery
8) sufficient function of important organs
9) written informed consent
Key exclusion criteria 1) with serious complications (intestinal paralysis, ileus, interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure etc)
with history of severe drug allergy
2) with clinically important infection
3) with diarrhea
4) with gastrointestinal bleeding need to repeat blood transfusion
5) with hepatocirrhosis or icterus
6) with clinically important mental disorder need to treat
7) with clinically important heart disease need to treat (ischemic heart disease, cardiac dysrhythmia etc)
8) with uncontrollable diabetes mellitus
9) pregnant or nursing women or women who like be pregnant and willing to get pregnant
10) doctor's decision not to be registered to this study
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsunehiro Takahashi
Organization School of Medicine, Keio University
Division name Departent of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

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

Sponsor
Institute 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
2010 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 12 Month 16 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=R000005633

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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