UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009528 |
|---|---|
| Receipt number | R000011180 |
| Scientific Title | Conversion Treatment in Unresectable Colorectal Cancer with Synchronous Liver Metastases Using Hepatic Artery Infusion Plus Systemic Chemotherapy |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2013/06/13 22:52:39 |
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Basic information
Public title
Conversion Treatment in Unresectable Colorectal Cancer with Synchronous Liver Metastases Using Hepatic Artery Infusion Plus Systemic Chemotherapy
Acronym
Treated the Synchronous Liver Metastases from Colorectal Cancer with Hepatic Artery Infusion
Scientific Title
Conversion Treatment in Unresectable Colorectal Cancer with Synchronous Liver Metastases Using Hepatic Artery Infusion Plus Systemic Chemotherapy
Scientific Title:Acronym
Treated the Synchronous Liver Metastases from Colorectal Cancer with Hepatic Artery Infusion
Region
| Asia(except Japan) |
Condition
Condition
Colorectal liver metastases
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evalue the potential benefit of hepatic artery infusion of floxuridine plus dexamethasone (Dex) and concurrent systemic chemotherapy with FOLFOX4
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival time
Key secondary outcomes
side effect, progression-free survival time; resectability rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
systymic chemotherapy with XELOX combined with HAI of FUDR and Dex
Interventions/Control_2
systemic chemotherapy with XELOX alone
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients had biopsy-proven colorectal cancer and unresectable synchronous liver metastases
2. the score of ECOG was less than
3.Age >=18 and 75=<
4.No prior surgery, radiation, chemotherapy
6.Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC >= 3000 /mm3 and <= 12,000 /mm3
Neu >= 1500 / mm3
Plt >= 75,000/mm3
T-Bil <= 2.5 times ULM
AST<= ULNx2.5
ALT<= ULNx2.5
Creatinine <=1.5 mg/dL
7.Written IC
Key exclusion criteria
1.Extrahepatic metastases
2.Imminent risk of obstruction or significant bleeding due to primary cancer
3. Previous or concurrent malignancy
4.Symptomatic psychological disease
5.Unsuitable to implant HAI pump by radiologic method because of the variations of the hepatic artery anatomy evaluated by computed tomography angiography (CTA)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shi Liangrong |
Organization
the Third Affiliated Hospital of Soochow University
Division name
Oncology Department
Zip code
Address
185 Juqian Street, Changzhou 213003, Jiangsu Province, China
TEL
86-519-68871122
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shi Liangrong |
Organization
the Third Affiliated Hospital of Soochow University
Division name
Oncology Department
Zip code
Address
185 Juqian Street, Changzhou 213003, Jiangsu Province, China
TEL
Homepage URL
shiliangr@126.com
Sponsor or person
Institute
Department of Oncology, the Third Affiliated Hospital of Soochow University
Institute
Department
Personal name
Funding Source
Organization
Department of
Science and Technology Changzhou
Organization
Division
Category of Funding Organization
Local Government
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 | 12 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2013 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011180
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
