UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000934 |
|---|---|
| Receipt number | R000001121 |
| Scientific Title | Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004) |
| Date of disclosure of the study information | 2007/12/08 |
| Last modified on | 2021/11/15 23:14:00 |
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Basic information
Public title
Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004)
Acronym
OGSG 0004
Scientific Title
Phase II study of preoperative TS-1+CDDP therapy for advanced gastric cancer (OGSG 0004)
Scientific Title:Acronym
OGSG 0004
Region
| Japan |
Condition
Condition
Patients with unresectable gastric cancer due to limited inavasion or metastasis.
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
TS-1 plus CDDP treatment is evaluated in terms of response rate and adverse events for patients with advanced gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate(RECIST),
probability on completion
Key secondary outcomes
Overall Survival, Resectability,
Recurrence Mode
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
Day1...day8.......day21...day35....day42.......day56
(--TS-1---------).......(---TS-1--------)
CDDP60mg/m2..................CDDP60mg/m2
.....................................2ws rest
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) Patients with unresectable advanced gastric cancer due to limited
inavasion or metastasis
2) cP0, CY0, cH0, cM0, and cT4, cN1, or cT2-4, cN2, cM1 (LYM)
*cM1(LYM): distant lymph nodes in the abdomen which can be removed
3) biopsy by endoscopy showed gastric cancer, histologically
4) without prior chemotherapy
5) with measurable metastatic lymph nodes in RECIST criteria
Measurable lesions: lesions larger than 10mm in spiral CT, or
20mm in common CT
6) without liver metastasis and/or peritoneal metastasis by abdominal echo,
CT or laparoscopy.
7) without distant metastasis by blood examination, or chest X-ray,
Without mediastinal lymph node metastasis by chast X-ray
8) age: =>20 and 75=>
9) Performance Status: 0-1 (ECOG criteria)
10) sufficient function of important organs
O WBC: >= 4,000 and =< 12,000/mm3
O Hb >=8.0g/dl
O Platelet: >= 100,000/mm3
O sGOT,sGPT: <100 IU/l
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= 1.2mg/dl
O respiratory function: PaO2 in room air >=70 torr
11) written informed consent
Key exclusion criteria
1) Under fresh bleeding from digestive tract
2) Patient who cannot take anticancer medicine orally due to gastrointestinal stenosis.
3) Type 4 gastric cancer
4) history of severe allergy against drug
5) under watery diarrhea
6) with sever disease on important organs (Infection, interstitial
pneumonitis, pulmonary fibrosis, cardiac disease, renal dysfunction, liver dysfunction, DM controlled by insulin)
7) double cancer without carcinoma in citu
8) pregnant women or women who like to be pregnant
9) doctor' s dicision not to be registered to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Nakane |
Organization
Kansai Medical University
Division name
Dpt. surgery
Zip code
Address
10-15 Fumizono-cho Moriguchi-shi 570-8506
TEL
06-6992-1001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Furukawa Hiroshi |
Organization
Sakai City Hospital
Division name
Director
Zip code
Address
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL
072-221-1700
Homepage URL
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
Funding Source
Organization
NPO Osaka Chinical Study Supporting Organization
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 | 08 | 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
| 2002 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001121
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