UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000786 |
|---|---|
| Receipt number | R000000943 |
| Scientific Title | Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer |
| Date of disclosure of the study information | 2007/08/09 |
| Last modified on | 2011/02/09 17:37:03 |
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Basic information
Public title
Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer
Acronym
OGSG0702
Scientific Title
Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer
Scientific Title:Acronym
OGSG0702
Region
| Japan |
Condition
Condition
Patients with advanced and/or recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Response rate and adverse events are evaluated in a phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate(RECIST)
Key secondary outcomes
Overall Survival, Progression Free Survival, Adverse Events, Incidence of Recruitement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:mFOLFOX6
Day 1 day 2 day 14
L-OHP
2HR
l-LV 200mg/m2 5-FU 2,400mg/m2 civ
2HR 46HR -------------
|
5-FU 400mg/m2 iv
Rapid
Interventions/Control_2
Group B:TS-1/CPT-11
CPT-11 80 mg/m2 CPT-11 80 mg/m2
1.5 hours 1.5 hours
TS-1 40-60 mg/m2
| | | |
Day 1 day 15 day 21 day 35
One course takes 35 days (5 weeks).
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) colon cancer proven histologically
2) with measurable metastatic lesions
3) without prior chemotherapy or with chemotherapy which is completed Before 6 months of registration
4) without radiation therapy
5) age: =>20 and 75=>
6) Performance Status: 0-1 (ECOG criteria)
7) more than 3 months of Expected survival period
8) sufficient function of important organs
O WBC: >= 4,000 and =< 12,000/mm3
O Neutrocyte: => 2,000/mm3
O Platelet: >= 100,000/mm3
O Hb: >= 9.0 g/dl
O sGOT,sGPT: 2.5 times of normal range in each institute
O sT.bil.: <= 1.5 mg/dl
O sCreatinin: <= upper limit of each institute
O Ccr from Cockcroft-Gault's method: >= 50 ml/min
O ECG: normal range
9) written informed consent
10) patients who can take food orally
Key exclusion criteria
1)Pulmonary fibrosis or Interstitial
Pneumonitis by chet X-ray examination
2)Cavity fluid which needs drainage
3)with active double cancer
4)with peripheral nerve disorder
5)with intestinal paralysis or
intestinal obstruction
6)under watery diarrhea
7)uncontrolled DM
8)with mental disorder which disturbs
registration to this study
9)with infectious disease
10)patients who receive steroids
treatment
11)Cardiac failure, liver dysfunction,
or renal dysfunction which disturb
Registration to this study
12)with brain metastasis and its symptom
13)pregnant women or women who like to
be pregnant
14)history of severe allergy against drug
15)patients receiving Atazanabil
16)doctor's dicision not to be
registered to this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomita Naohiro |
Organization
Hyogo College of Medicine
Division name
Dpt. surgery
Zip code
Address
1-1, Kawamachi, Muko, Nishinomiya-shi, Hyogo 663-8131
TEL
0798-45-6111
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
furukawa-h@sakai-hospital.jp
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 | 08 | Month | 09 | 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
| 2007 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | 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
| 2007 | Year | 08 | Month | 02 | Day |
Last modified on
| 2011 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000943
| 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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