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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000920
Receipt No. R000001014
Scientific Title Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer
Date of disclosure of the study information 2007/12/02
Last modified on 2015/06/14

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Basic information
Public title Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer
Acronym Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer
Scientific Title Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer
Scientific Title:Acronym Feasibility study of adjuvant therapy with S-1 plus CDDP in gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the feasibility and safety of adjuvant treatment with a combination of S-1 plus CDDP in patients with gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Treatment compliance with 3 courses of S-1 plus CDDP
Key secondary outcomes Treatment compliance with 2 courses of S-1 plus CDDP, proportion of patients receiving treatment according to protocol, and adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adjuvant chemotherapy (S-1 monotherapy followed by S-1+CDDP therapy followed by S-1 monotherapy)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proved adenocarcinoma of stomach
2) >=D2 lymph node dissection, curability B
3) Stage IIIA/IIIB (Japanese classification)
4) ECOG performance status 0-1
5) Age between 20 and 75 years
6) No prior chemotherapy or radiotherapy
7) Able to be enrolled between 4 and 6 weeks after surgery
8) Enough oral food intake possible between 4 and 6 weeks after surgery
9) Adequate organ function
10) Written informed consent
Key exclusion criteria 1)synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2)pregnant or breast-feeding women
3)severe mental disease
4)systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
5)other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
6)myocardial infarction within the past 6 months
7)Inadequate physical condition, as diagnosed by primary physician
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Hamaguchi
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email thamaguc@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Takahari
Organization Aichi Cancer Center Hospital
Division name Medical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL 052-762-6111
Homepage URL
Email dtakahari@aichi-cc.jp

Sponsor
Institute National Cancer Center Hospital
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
2007 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1007/s00280-010-1432-8
Number of participants that the trial has enrolled
Results
A total of 63 enrolled patients have been evaluated. Grade 3/4 toxicities included neutropenia (40%), anorexia (28%), and febrile neutropenia (4%) before protocol amendment (n = 25), and neutropenia (37%), anorexia (8%), and febrile neutropenia (3%) after amendment implementation (n = 38). Excluding ineligible cases, treatment completion rates were 57% (12/21) before and 81% (30/37) after the protocol amendment.
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 Main results already published
Date of protocol fixation
2007 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information We undergo 5 year survival analysis.

Management information
Registered date
2007 Year 12 Month 02 Day
Last modified on
2015 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001014

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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