Unique ID issued by UMIN | UMIN000007272 |
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Receipt number | 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 21:10:24 |
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
Study of neoadjuvant chemotherapy on the biomarker profiles of colorectal cancers (bTAC trial)
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
Study of neoadjuvant chemotherapy on the biomarker profiles of colorectal cancers (bTAC trial)
Japan |
Colorectal cancer with unresectable liver metastasis
Gastrointestinal surgery |
Malignancy
YES
To study about the effect of neoadjuvant chemotherapy on biomarker profiles of colorectal cancers
Others
To explore biomarkers in chemotherapy treatment
Exploratory
Changes of biomarker molecules on the genetic and protein levels
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
15
1st name | Tadahiko |
Middle name | |
Last name | Masaki |
Kyorin university hospital
Surgery
181-8611
6-20-2 Shinkwa, Mitaka, Tokyo
0422475511
masaki@ks.kyorin-u.ac.jp
1st name | Takaaki |
Middle name | |
Last name | Kobayashi |
Kyorin university hospital
Surgery
181-8611
6-20-2 Shinkwa, Mitaka, Tokyo
0422475511
ck9t-kbys@asahi-net.or.jp
Surgery, Kyorin university hospital
Surgery, Kyorin university hospital
Self funding
Kyorin university hospital
6-20-2 Shinkwa, Mitaka, Tokyo
0422475511
ck9t-kbys@asahi-net.or.jp
NO
2012 | Year | 02 | Month | 13 | Day |
https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
Unpublished
https://www.kyorin-u.ac.jp/hospital/clinic/surgery16/surgery16research.html
10
The target number of cases was 42, and the number of participants was 10. The analysis was impossible.
2020 | Year | 09 | Month | 01 | Day |
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.
Examine the expression of target genes before and after chemotherapy.
Nothing in particular
Expression of the following target genes
K-ras, Braf, p53, PTEN, PI3K, c-Met, EGFR, VEGFR, VEGF, c-Kit, HGF, PDGFR
Terminated
2012 | Year | 01 | Month | 01 | Day |
2012 | Year | 01 | Month | 31 | Day |
2012 | Year | 01 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
Prospective study at meeting the condition
2012 | Year | 02 | Month | 12 | Day |
2020 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008579
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