UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000443 |
|---|---|
| Receipt number | R000000526 |
| Scientific Title | Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer |
| Date of disclosure of the study information | 2006/07/04 |
| Last modified on | 2018/10/15 13:12:31 |
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Basic information
Public title
Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer
Acronym
SOX
Scientific Title
Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer
Scientific Title:Acronym
SOX
Region
| Japan |
Condition
Condition
unresectable advanced/recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of L-OHP combined with S-1 in patients with advanced/recurrent colorectal cancer, and to evaluate safety and clinical response with this therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Step1:safety;adverse events
Step2:Disease control rate
Key secondary outcomes
Step1:Eficacy (response rate(CR+PR),disease control rate, survival
Step2: Safety, Response rate, survival
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
S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest.
L-OHP is administered intravenously biweekly(day 1 and 15).
On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses.
The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0.
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) With histologically or cytologically confirmed colorectal cancer
2) unresectable disease
3) Patients who have measurable lesions with RECIST criteria
4) Previous treatment with one regimens is allowed. At least 4 weeks interval from the last administration of previous chemotherapy
5) Age 20 to 74 years.
6) PS 0-1(ECOG).
7) Life-expectancy is more than 3 months
8) Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria:
WBC > 4000/mm3 and <12000/mm3,
Granulocyte count > 2000/mm3,
Platelet count > 100,000/mm3,
Hb > 9.0 g/dl
AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl
Serum creatinine < upper normal limit
Cockroft-Gault CCr > 50ml/min
9) Written informed consent prior to the enrollment of the study.
10) adequate oral intake
Key exclusion criteria
1) during flucytosine medication
2) Active infection or inflammation
3) Uncontrolled severe Diabtes
4) patient severe medical condition
5) patient with interstitial pneumonitis or the history
6) patient with active gastrointestinal bleeding
7) patient with severe neurotoxicity
8) patient with active chicken pox
9) patient with metastasis of CNS
10) patient with other concurrent malignancy affecting on survival or adverse events
11) pregnant or nursing patient or with intent to bear baby
12) patient with allergic history to drug
13) patient with massive effusion of massive ascites
14) patient evaluated to be inadequate by a attending doctor
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigemi Matsumoto |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan
TEL
075-751-4770
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemi Matsumoto |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan
TEL
075-751-4770
Homepage URL
motocame@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Outpatient Oncology Unit
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
| 2006 | Year | 07 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000526
