UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006783 |
|---|---|
| Receipt number | R000008028 |
| Scientific Title | PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases |
| Date of disclosure of the study information | 2011/11/28 |
| Last modified on | 2018/09/27 11:14:28 |
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Basic information
Public title
PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases
Acronym
N-SOG 07
Scientific Title
PhaseII trial of neoadjuvant chemotherapy for recurrent colorectal cancer with resectable extra hepatic metastases
Scientific Title:Acronym
N-SOG 07
Region
| Japan |
Condition
Condition
recurrent colorectal cancer with resectable extra hepatic metastases
Classification by specialty
| Surgery in general | 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 for recurrent colorectal cancer with resectable extra hepatic metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
treatment completion rate
Key secondary outcomes
R0 resection rate, pCR rate, adverse event, response rate, recurrence free survival, 3-year disease free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy with FOLFOX plus panitumumab followed by surgery
Interventions/Control_2
Neoadjuvant chemotherapy with FOLFIRI plus panitumumab followed by surgery
Interventions/Control_3
Neoadjuvant chemotherapy with FOLFOX plus bevacizumab followed by surgery
Interventions/Control_4
Neoadjuvant chemotherapy with FOLFIRI plus bevacizumab followed by surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed adenocarcinoma of colorectal cancer
2) Chemotherapy un-treating and having existing treated do not ask.
3) Analysis result of KRAS gene becomes clear by 2 course start
4) Recurrent colorectal cancer with resectable extra hepatic metastases
5) Already resected, or resectable
6)Without prior surgery,chemotherapy,
radiotherapy and radiofrequency ablation for the target metastases
7)Performance status(PS) 0-1
8)Age:20-80 years
9)Alife expectancy greater than 12 weeks
10)Adequate organ function within 14 days before chemotherapy
11) Written informed consent
Key exclusion criteria
1)History of drug hypersensitivity
2)Dysesthesia
3) Contraindications to using drugs
4)Multiple malignacies to be treated
5)Have hematopoietic drugs within 7days before enrollment
6)Uncontrolled body cavity fluid
7)Serious infection
8)With brain metastases
9)Significant abnormal ECG or history of cardiovascular disease
10)Serious lung disease
11)With hemorrhage
12)Uncontrolled diarrhea
13)With Intestinal paralysis, or obstruction
14)History of central nervous system disorder
15) With dementia,or severe mental disorder
16) Gravida or lactating woman
17)Not suitable for participation with any other reasons
Target sample size
40
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
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
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
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
| 2011 | Year | 11 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008028
