Unique ID issued by UMIN | UMIN000021324 |
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Receipt number | R000024136 |
Scientific Title | Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer |
Date of disclosure of the study information | 2016/03/03 |
Last modified on | 2018/03/29 20:55:56 |
Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal or appendiceal cancer
Japan |
Peritoneal metastasis from colorectal or appendiceal cancer
Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
Malignancy
NO
To evaluate the feasibility and safety of neoadjuvant intravenous and intraperitoneal chemotherapy for peritoneal metastasis from colorectal cancer
Safety
Exploratory
Phase I,II
Safety
Overall response rate, 1-year overall survival rate, rate of response in PCI score
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous chemotherapy (IV) is given on days 1 and 15 and PTX is given intraperitoneally (IP) at 20 mg/m2 on days 1, 8 and 15. This regimen is repeated every 4 weeks.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Histologically proven colorectal or appendiceal cancer; peritoneal metastasis; age between 20 and 80 years; Synchronous or metachronous metastasis; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >75,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.
Metastasis to distant organ sites (such as liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.
20
1st name | |
Middle name | |
Last name | Hideaki Yano |
National Center for Global Health and Medicine
Department of Surgery
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
yano-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Yoshimasa Gohda |
National Center for Global Health and Medicine
Department of Surgery
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
03-3202-7181
yoshi-gouda@hotmail.co.jp
National Center for Global Health and Medicine
none
Other
NO
2016 | Year | 03 | Month | 03 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 12 | Day |
2013 | Year | 09 | Month | 12 | Day |
2016 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2016 | Year | 03 | Month | 03 | Day |
2018 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024136
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