UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000920 |
|---|---|
| Receipt number | 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 12:51:31 |
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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
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
dtakahari@aichi-cc.jp
Sponsor or person
Institute
National Cancer Center Hospital
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001014
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
