UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006994 |
|---|---|
| Receipt number | R000008253 |
| Scientific Title | 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 | 2020/07/07 09:24:16 |
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Basic information
Public title
Phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Acronym
TAMA conversion trial (TAC trial)
Scientific Title
Phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Scientific Title:Acronym
TAMA conversion trial (TAC trial)
Region
| Japan |
Condition
Condition
Colorectal cancer patients with unresectable liver metastasis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Study on the efficacy and safety of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate in FOLFIRI+Cetuximab treatment
Key secondary outcomes
R0 resection rate in FOLFOX+Bevacizumab treatment, response rate and efficacy in both treatments
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 with histologically proven colorectal cancers
2)Men and women aged 20 or over
3)Patients with evaluable lesions (RECIST criteria)
Synchronous or metachronous liver metastasis (cases with metastasis outside the liver or regional lymph nodes are excluded)
In a case of synchronous liver metastasis, any treatments except for resection of the primary tumor are not permitted, and at least 4weeks should have passed after resection of the primary tumor.
In a case of metachronous liver metastasis, any treatments for liver metastasis are not permitted, and at least 6 months should have passed after adjuvant chemotherapy for the primary tumor.
4)Margin-free metastatectomy is assumed to be impossible.
5)The estimated residual liver volume after resection is assumed to be less than 40%.
6)The Eastern Cooperative Oncology Group(ECOG) Performance Status is 0 or 1.
7)Estimated survival time after treatment starts is assumed to be 3 months or more.
8)Informed consent should be complete, and written consent should be given by patients themselves
9)Within 2 weeks before treatment, laboratory data should meet the following criteria. If there are several test results during the due course, the most adjacent result should be adopted. No use of BTF and G-CSF within 2 weeks before the blood test is permitted.
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 previous histories of severe drug hypersensitivity or drug allergies
2) Patients with multiple primaries
3) Patients with metastasis outside the liver and regional lymph nodes
4) Patients with infection (fever of 38 degrees C or over)
5) Patients with severe comobidities (interstitial pneumonia or pulmonary fibrosis, cardiac failure, renal failure, liver failure, uncontrollable diabetes or hypertension, jaundice)
6) Patients with pleural effusion or ascites requiring treatment
7) Patients with diarrhea (watery)
8) Patients receiving atazanavir sulfate or flucytosine treatment
9) Pregnant women and women suspected of being pregnant and lactating women
10) Patients evaluated as unsuitable for this trial by the doctor in charge
11) Patients with arterial or venous thrombosis in KRAS mutant cases
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 | 05 | Month | 19 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To administer FOLFIRI+Cetuximab to patients with Kras-wild type, FOLFOX+Bevacizumab to patients with Kras-mutation type
Management information
Registered date
| 2011 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008253
| 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 |
