UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004706
Receipt No. R000005590
Scientific Title PhaseII trial of neoadjuvant chemotherapy with TS-1, Oxaliplatin and Bevacizumab for resectable liver metastases from colorectal cancer
Date of disclosure of the study information 2010/12/13
Last modified on 2011/10/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title PhaseII trial of neoadjuvant chemotherapy with TS-1, Oxaliplatin and Bevacizumab for resectable liver metastases from colorectal cancer
Acronym N-SOG 05
Scientific Title PhaseII trial of neoadjuvant chemotherapy with TS-1, Oxaliplatin and Bevacizumab for resectable liver metastases from colorectal cancer
Scientific Title:Acronym N-SOG 05
Region
Japan

Condition
Condition Resectable colorectal liver metastases
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjuvant chemotherapy with SOX plus Bevacizumab for resectable liver metastases from colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes PFS, Responce rate, adverse event rate, Relative dose intensity (RDI)

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 Neoadjuvant chemotherapy with SOX plus Bevacizumab followed by surgery
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histopathologically confirmed adenocarcinoma of colorectal cancer
2)Resectable liver metastases from colorectal cancer except extrahepatic metastases
3)Age:20-79 years at registration
4)Confirmed liver metastases by chest,abdominal and pelvic CT and EOB-MRI, and no extrahepatic metastases
5)Performance status(PS)0-1
6)Without prior chemotherapy (including hepatic artery infusion) or RFA for liver metastases
7)Oral intake is possible
8)Adequate organ function (within 14 days before chemotherapy):
9)Alife expectancy greater than 3 months
10)Written informed consent
Key exclusion criteria 1) Active double cancer
2) Active infection
3) Fever of >= 38 degrees Celsius
4) Pregnant or nursing females. Males who are planning partners' pregnancy.
5)Severe mental disorder
6)Systemic administration of corticosteroids
7)Serious complications
8)Abnormal in electrocardiogram within 28 days before chemotherapy or clinically significant heart disease
9)Neuropathy
10)Uncontrolled diarrhea
11)Massive pleural or abdominal effusion
12)Brain metastases
13)History of thromboembolism, cerebral infarction, pulmonary infraction or interstitial pneumonia
14)Surgery within 28 days before chemotherapy
15)History of hypersensitivity for Oxaliplatin
16)History of hypersensitivity for TS-1
17)History of hypersensitivity for Bevacizumab
18)Under treatment with fluoropyrimidine except TS-1
19)Under treatment with flucytosine
20)Pretreatment with TS-1, Oxaliplatin or Bevacizumab
21)High grade stenosis at the primary tumor
22)Massive peritoneum dissemination
23)Bleeding (Congenital hemorrhagic disease) or coagulation disorder
24)Under treatment with anticoagulant
25)History of gastrointestinal perforation within 6 months before registration
26)History of hemoptysis
27)Not suitable for participation with any other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nagino
Organization Nagoya University Graduated School of Medicine
Division name Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL 052-744-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Uehara
Organization Nagoya University Graduated School of Medicine
Division name Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL 052-744-2222
Homepage URL
Email kuehara@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Surgical Oncology Group
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
2010 Year 12 Month 13 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 Enrolling by invitation
Date of protocol fixation
2010 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 11 Day
Last modified on
2011 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.