UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007411 |
|---|---|
| Receipt number | R000008731 |
| Scientific Title | A phase II Study of Useful therapeutic strategy for metastatic Colorectal Cancer to Evaluate Oxaliplatin Stop and Go in SOX+Bmab |
| Date of disclosure of the study information | 2012/02/29 |
| Last modified on | 2013/10/04 09:22:52 |
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Basic information
Public title
A phase II Study of Useful therapeutic strategy for metastatic Colorectal Cancer to Evaluate Oxaliplatin Stop and Go in SOX+Bmab
Acronym
SUCCESS
Scientific Title
A phase II Study of Useful therapeutic strategy for metastatic Colorectal Cancer to Evaluate Oxaliplatin Stop and Go in SOX+Bmab
Scientific Title:Acronym
SUCCESS
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of Oxaliplatin stop and go in TS-1 and Oxaliplatin and Bevacizumab for advanced and recurrent colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free Survival
Key secondary outcomes
Overall Survival, Response Rate, Safety
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
TS-1 80mg/m2/day (day1-14) and Oxaliplatin 130mg/m2 (day1) and Bevacizumab 7.5mg/kg (day1) every 21 days for 4 courses followed by TS-1 80mg/m2/day (day1-14) and Bevacizumab 7.5mg/kg (day1) every 21 days for 8 courses. And next, administer until PD the same SOX+Bmab regimen.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed Colorectal Cancer(Adeno Carcinoma)
2)Stage IV and chemotherapy naive patients
3) aged 20 years or older
4)Performance Status(ECOG):0-1
5)Oral intake is possible
6)Adequate organ functions
7)Written informed consent
Key exclusion criteria
1)Contraindication of TS-1, Oxaliplatin and Bevacizumab.
2)Patients with severe complications,(heart failure, renal failure, liver failure, peptic ulcer hemorrhage, intestinal paralysis, intestinal obstruction, Peritonitis or uncontrollable diabetes mellitus or hypertension)
3)Patients with History of severe drug allergy, pulmonary fibrosis, interstitial pneumonitis, Thrombosis/embolism, Cerebral infarction, pulmonary infarction or hemoptysis.
4)Patients with severe diarrhea
5) Patients with sensory neuropathy
6)Patients with serious infections or susupected infections with fever(over 38 degree)
7)HBs Ag is positive
8)Complication of ascites or pleural effusion requiring treatment such as the drainage
9) Patients with the primary tumor with the high-grade stenosis as an endoscope do not pass.( However, the case of excision of the primary tumor or the stoma is possible.)
10) Patients with the peritoneal metastasis which we can confirm with an image
11)concomitant therapy with flucytocine, phenytoin or warfarin
12)Pregnant, breast feeding, or men in hope of Pregnancy of partner.
13)Relapse of administering period and less than 6 months of TS-1 or Oxaliplatin.
14) Patients with the continuous systemically administration of steroid.
15) Active concomitant malignancy with less than five years in disease free interval.
16)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kajiwara |
Organization
Uwajima City Hospital
Division name
Surgery
Zip code
Address
1-1, Gotenmachi, Uwajima-shi, Ehime 798-8510 (Japan)
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Imai |
Organization
Uwajima City Hospital
Division name
Surgery
Zip code
Address
1-1, Gotenmachi, Uwajima-shi, Ehime 798-8510 (Japan)
TEL
Homepage URL
Sponsor or person
Institute
Uwajima City Hospital
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
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
| 2012 | Year | 02 | Month | 29 | 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
| 2012 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2012 | Year | 02 | Month | 29 | Day |
Last modified on
| 2013 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008731
