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

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 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

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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name