UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006995 |
|---|---|
| Receipt number | R000008257 |
| Scientific Title | Basic analysis of new evaluation method in neoadjuvant chemotherapy (Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer) |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2020/09/01 19:32:22 |
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Basic information
Public title
Basic analysis of new evaluation method in neoadjuvant chemotherapy
(Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer)
Acronym
CTC in neoadjuvant chemotherapy trial (cTAC trial)
Scientific Title
Basic analysis of new evaluation method in neoadjuvant chemotherapy
(Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer)
Scientific Title:Acronym
CTC in neoadjuvant chemotherapy trial (cTAC trial)
Region
| Japan |
Condition
Condition
Colorectal cancer with unresectable liver mttastasis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of CTC as new evaluation method in neoadjuvant chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To study correlation with rate of tumor shrinkage by CT, rate of tumor maker decrease and CTC changes
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients who has been histologically diagnosed with colorectal cancer
2) Men and women aged 20 or over
3) Patients with evaluable lesions (RECIST criteria )
Synchronous or metachronous liver metastasis (exclude metastasis except for liver and regional lymph nodes)
In the case of synchronous liver metastasis, there are no treatments except for resection of primary tumor and it takes at least 4weeks from esection of primary tumor
In the case of metachronous liver metastasis, there are no treatments for liver metastasis and it takes at least 6 months from adjuvant chemotherapy for primary tumor
4) Patients with metastastic tumors that it is impossible to resect them without tumor exposure
5) After liver resection, the estimated volume of resirual live will be under 40%
6) The Eastern Cooperative Oncology Group(ECOG) Performance Status is 0 or 1
7) Estimated survival time since treatment starts is 3 months or over
8) Patients with enough explanation and written consent
9) Within 2 weeks before treatment, patients meet below criteria. If there are some test results during appropriate time, adjacent result is adopted. No use of BTF and G-CSF before within 2 weeks before blood test
i)hematopoietic function
WBC:>3000/mm3
neutrophi:>1500/mm3
Plt:>100000/mm3
Hb:>9.0g/dL
ii)liver function
AST(GOT):<ULNx2.5
AST(GPT):<ULNx2.5
T-Bil:<ULNx2
iii)renal function
Cr:<ULNx2
Key exclusion criteria
1) Patients with known severe drug hypersensitivity or drug allergies
2) Multiple primaries
3) Metastasis except for liver and regional lymph nodes
4)Infection (fever of 38 degrees C or over)
5) Severe complications (interstitial pneumonia or pulmonary fibrosis, cardiac failure, renal failure, liver failure, uncontrollable diabetes or hypertension, jaundice)
6) Pleural effusion or ascites requiring treatment
7) Diarrhea (water like)
8) During treatment of atazanavir sulfate or flucytosine
9) Pregnant women and women suspected of being pregnant and lactating woman
10) Doctor evaluate inappropriate
11) Thrombosis in arteries or veins
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Masaki |
Organization
Kyorin university hospital
Division name
Surgery
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422475511
ck9t-kbys@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyorin university hospital
Division name
Surgery
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422475511
Homepage URL
ck9t-kbys@asahi-net.or.jp
Sponsor or person
Institute
Surgery, Kyorin university hospital
Institute
Department
Personal name
Funding Source
Organization
Surgery, Kyorin university hospital
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
Kyorin university hospital
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422475511
ck9t-kbys@asahi-net.or.jp
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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
Number of participants that the trial has enrolled
10
Results
This clinical trial was discontinued due to a lack of case accumulation.
Results date posted
| 2020 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This clinical trial was discontinued due to a lack of case accumulation.
Participant flow
This clinical trial was discontinued due to a lack of case accumulation.
Adverse events
This clinical trial was discontinued due to a lack of case accumulation.
Outcome measures
This clinical trial was discontinued due to a lack of case accumulation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To study the efficacy of CTC in neoadjuvant chemotherapy
Management information
Registered date
| 2011 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008257
