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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007272
Receipt No. R000008579
Scientific Title Basic study about the effect of neoadjuvant chemotherapy on the biomarker profiles Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Date of disclosure of the study information 2012/02/13
Last modified on 2020/09/01

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Basic information
Public title Basic study about the effect of neoadjuvant chemotherapy on the biomarker profiles
Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Acronym Study of neoadjuvant chemotherapy on the biomarker profiles of colorectal cancers (bTAC trial)
Scientific Title Basic study about the effect of neoadjuvant chemotherapy on the biomarker profiles
Additional study of phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
Scientific Title:Acronym Study of neoadjuvant chemotherapy on the biomarker profiles of colorectal cancers (bTAC trial)
Region
Japan

Condition
Condition Colorectal cancer with unresectable liver metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To study about the effect of neoadjuvant chemotherapy on biomarker profiles of colorectal cancers
Basic objectives2 Others
Basic objectives -Others To explore biomarkers in chemotherapy treatment
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of biomarker molecules on the genetic and protein levels
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 15

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 181-8611
Address 6-20-2 Shinkwa, Mitaka, Tokyo
TEL 0422475511
Email masaki@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name Kobayashi
Organization Kyorin university hospital
Division name Surgery
Zip code 181-8611
Address 6-20-2 Shinkwa, 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 Shinkwa, 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 02 Month 13 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
The target number of cases was 42, and the number of participants was 10. The analysis was impossible.
Results date posted
2020 Year 09 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who participated in the phase II clinical trial (pre-study) of preoperative chemotherapy for unresectable liver metastases of colorectal cancer and who agreed to participate in the ancillary study.
Participant flow
Examine the expression of target genes before and after chemotherapy.
Adverse events
Nothing in particular
Outcome measures
Expression of the following target genes
K-ras, Braf, p53, PTEN, PI3K, c-Met, EGFR, VEGFR, VEGF, c-Kit, HGF, PDGFR
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
2012 Year 01 Month 31 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study at meeting the condition

Management information
Registered date
2012 Year 02 Month 12 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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