UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006994
Receipt No. 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 (Ver. 4)

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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
Email 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
Email ck9t-kbys@asahi-net.or.jp

Sponsor
Institute Surgery, Kyorin university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008253