UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015723 |
|---|---|
| Receipt number | R000018281 |
| Scientific Title | Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06) |
| Date of disclosure of the study information | 2014/11/19 |
| Last modified on | 2019/07/30 13:16:31 |
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Basic information
Public title
Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06)
Acronym
KOGC-06
Scientific Title
Phase 1 study of Docetaxel and Oxaliplatin and TS-1 for unresectable / recurrent gastric cancer (KOGC-06)
Scientific Title:Acronym
KOGC-06
Region
| Japan |
Condition
Condition
unresectable / recurrent gastric cancer
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess maximum tolerated dose in order to determine recommended dose of Docetaxel and Oxaliplatin and TS-1 in patients with unresectable or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence of dose limiting toxicity
Key secondary outcomes
Overall Response rate
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
Docetaxel and Oxaliplatin and TS-1concurrent therapy :
Level 1
Docetaxel : 32 mg/m2 i.v. (day1)
Oxaliplatin : 105 mg/m2 i.v. (day1)
TS-1 : 80 mg/m2/day p.o. (day1-14)
to be repeated every 3 weeks.
Docetaxel is administered with an initial dose of 32mg/m2, stepped up to 40mg/m2.
Oxaliplatin is administered with an initial dose of 105mg/m2, stepped up to 130mg/m2.
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) Histological confirmation of gastric cancer.
(2) Patients with an unresectable or recurrent gastric cancer.
(3) Patients with confirmation of measurable or evaluable lesions within 28 days prior to entry.
(4) No prior treatment of Docetaxel or Oxaliplatin or TS-1.
(5) No prior treatment of radiation.
(6) age: >=20 and <75 when received informed consent.
(7) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 -1.
(8) Life expectancy estimate 3 months, and more.
(9) Vital organ functions (listed below) are preserved within 14 days prior to entry.
Neutrophils>=1,500/mm3
Platelets>=100,000/mm3
Hemoglobin>=8.0 g/dl
AST and ALT <=100 I/U
Total bilirubin<=1.5 mg/dl
Serum creatinine <= 1.2 mg/dl
Estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min
(10) Patients able to oral intake
(11) Written informed consent.
Key exclusion criteria
(1) Patients with severe ischemic heart disease or arhythmia.
(2) Patients with myocardial infarction within 6 months.
(3) Patients with liver cirrhosis or active hepatitis.
(4) Patients with dyspnea needing oxygen.
(5) Patients with fresh gastrointestinal bleeding which require a repeat blood transfusion.
(6) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication.
(7) Patients with uncontrolled diabetes mellitus.
(8) Patients with ileus or subilues.
(9) Patients with fever infection.
(10) Patients who have history of active simultaneous or metachronous double cancers within 5 year.
However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.
(11) Patients with CNS metastases.
(12) Patients with acute infectious diseases.
(13) Patients with peripheral neuropathy.
(14) Patients with history of severe adverse event suspected to be caused by drugs.
(15) Patients with history of severe adverse event suspected to be caused by Polyoxyethylene Castor Oil or hydroxyohlorinatedcasteroil.
(16) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers.
(17) Patients who are inappropriate for the study at the physician's assessment.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
hkawakubo@z3.keio.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hkawakubo@z3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Surgery
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
| 2014 | Year | 11 | Month | 19 | 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
5
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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018281
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