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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007411
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Uwajima City Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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