UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003796 |
|---|---|
| Receipt number | R000004527 |
| Scientific Title | Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group |
| Date of disclosure of the study information | 2010/06/22 |
| Last modified on | 2010/06/29 16:51:51 |
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Basic information
Public title
Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group
Acronym
Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases
(COMET)
Scientific Title
Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases(CML) from tokai digestive cancer trials group
Scientific Title:Acronym
Neoadjuvant Chemotherapy with Oxaliplatin plus Fluorouracil l-Leucovorin or Oxaliplatin plus Capecitabin and MoAb for resectable colorectal liver metastases
(COMET)
Region
| Japan |
Condition
Condition
Resectable Liver Metastases From Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Multicenter phase II study of oxaliplatin plus fluoro-uracil l-Leucovorin or oxaliplatin plus capecitabine and MoAb as neoadjuvant chemotherapy for patients with resectable liver metastases from colorectal cancer in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
anti-tumor effect
overall survival
R0 resection rate
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 | Maneuver |
Interventions/Control_1
Patients receive FOLFOX regimen or XELOX (oxaliplatin plus capecitabin) and MoAb as neoadjuvant protocol
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
2,KRAS mutation status was determined
3,Resectable liver metastases with or without lymphnode metastases
4,No extrahepatic disease
5,No prior chemotherapy , immunotherapy and radiotherapy except adjuvant chemotherapy if ended >=6 months before study entry
6,No prior radiofrequency ablation or surgery for liver metastases
7,No prior radiotherapy for liver metastases
8,ECOG performance status <=1
9,Adequate hematological, renal and liver function
10,Written informed consent
Key exclusion criteria
1,Serious myelosuppression
2.Serious infection
3,Large quantity of abdominal or pleural effusion
4,cardiovascular disease, complication
5,sensory alteration or paresthesia interfering with function
6,No brain or bone metastasis, active double cancer
7,No hypersensitivity for test drugs
8,Serious pulmonary disease
9,Liver cirrhosis
10,Multiple cancer patient
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kondo |
Organization
Nagoya Medical Center
Division name
Department of Surgery
Zip code
Address
4-1-1Sannomaru Naka-Ku Nagoyasi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name
Young Leaders Program in Medical Administration
Zip code
Address
65 Turumaicho Shouwa-ku, Nagoya Japan
TEL
Homepage URL
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network
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
| 2010 | Year | 06 | Month | 22 | 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
| 2010 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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 | 06 | Month | 21 | Day |
Last modified on
| 2010 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004527
