UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000903 |
|---|---|
| Receipt number | R000001089 |
| Scientific Title | Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703) |
| Date of disclosure of the study information | 2007/11/24 |
| Last modified on | 2021/11/15 23:09:13 |
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Basic information
Public title
Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)
Acronym
OGSG 0703
Scientific Title
Phase I study of TS-1+CDDP+PTX therapy in patients with advanced/recurrent gastric cancer (OGSG 0703)
Scientific Title:Acronym
OGSG 0703
Region
| Japan |
Condition
Condition
Patients with unresectable or metastatic gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A new treatment methd will be developed using TS-1, CDDP and PTX for unresectable or metastatic gastric cancer. The recommendable use and dose should be decided through adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse Events, maximum tolerated dose, recommended dose
Key secondary outcomes
Response Rate(RECIST)
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........day15.......day21.......day35
CDDP....*...............*
PTX........*...............*
TS-1......80, 100, 120mg/day.......interval
.................Day1 - day21............day22-day35
.....................One course takes 5 weeks.
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) gastric cancer proven histologically
2) with measurable lesion or detectable lesion
3) without prior chemotherapy (radiation therapy, chemotherapy or hormone therapy)
Patients with the last prior therapy before more than 4 weeks of
registration can be registered.
4) sufficient function of important organs from the deta before 2 weeks of registration
O hemoglobin: >= 8.0 mg/dl
O WBC: >= 4,000 and =< 12,000/mm3
O Platelet: >= 100,000/mm3
O sGOT,sGPT: < 100 IU/L
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= upper limit of each institute
*Creatinin clearance: >= 60 ml/min (Cockcroft-Gault method)
5) age: =>20 and 75=>
6) Performance Status: 0-1 (ECOG criteria)
7) more than 3 months of expected survival period
8) patients who can take food orally
9) written informed consent
Key exclusion criteria
1) with fresh intestinal bleeding
2) patient who cannot be administered anticancer agents due to intestinal obstraction
3) history of severe allergy against drug
4) with severe thoracic fluid and/or ascites
5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, liver dysfunction, renal dysfunction or uncontrolled DM) which disturb registration to this study
6) with liver scirrhosis and/ or jaundice
7) patients with mental disprder who need medicines and/or treatments
8) with brain metastasis and its symptoms
9) with active double cancer
10) pregnant women or women who like to be pregnant
11) doctor's dicision not to be registered to this study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Yutaka |
Organization
NTT West Osaka Hospital
Division name
Dpt.Digestive Diseases
Zip code
Address
2-6-40Karasugatuji Tennnouji-Ku Osaka543-8922
TEL
06-6773-7111
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 | 11 | Month | 24 | 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
| 2007 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 22 | 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=R000001089
