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

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007272

Enrollment

Registered

2012-02-13

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer with unresectable liver metastasis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes of biomarker molecules on the genetic and protein levels	—

Countries

Japan

Contacts

Public ContactTakaaki Kobayashi

Kyorin university hospital Surgery

ck9t-kbys@asahi-net.or.jp0422475511

Outcome results