Unique ID issued by UMIN | UMIN000012054 |
---|---|
Receipt number | R000014073 |
Scientific Title | Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer |
Date of disclosure of the study information | 2013/10/16 |
Last modified on | 2013/10/15 19:49:01 |
Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer
Phase I study of S-IROX for advanced pancreatic cancer
Phase I study of S-1, irinotecan plus oxaliplatin combination therapy (S-IROX) for advanced pancreatic cancer
Phase I study of S-IROX for advanced pancreatic cancer
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Adult |
Malignancy
YES
The aim of this study is to determine the recommended dose for the phase II study based on the observed dose-limiting toxicities.
Safety
Exploratory
Pragmatic
Phase I
Safety
Frequency of DLTs
response rate, progression-free survival, overall survival, and adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
L-OHP: fixed dose
IRI: dose escalation
S-1: dose escalation
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Pathologically diagnosed invasive ductal carcinoma
2) Unresectable locally advanced, metastatic, or recurrent disease
3) No prior chemotherapy or radiotherapy for pancreatic cancer
4) Aged 20 to 75 years old
5) ECOG PS of 0 or 1
6) Adequate organ functions
7) Sufficient oral intake
8) Written informed consent
1) Grade 2 or greater peripheral neuropathy
2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene
3) Moderate ascites
4)Intestinal pneumonitis or pulmonary fibrosis
5) Uncontrollable diarrhea
6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders)
8) Active double cancer
9) Pregnancy
10)Inappropriate for this study judged by the attending physician
24
1st name | |
Middle name | |
Last name | Hideki Ueno |
National Cancer Center Hospital
Hepatobiliary and Pancreatic Oncology Division
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
hiueno@ncc.go.jp
1st name | |
Middle name | |
Last name | Satoshi Shiba |
National Cancer Center Hospital
Hepatobiliary and Pancreatic Oncology Division
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
03-3542-2511
sashiba@ncc.go.jp
National Cancer Center Hospital
Ministry of Health, Labor and Welfare
Japan
NO
国立がん研究センター中央病院
2013 | Year | 10 | Month | 16 | Day |
Unpublished
Open public recruiting
2013 | Year | 09 | Month | 12 | Day |
2013 | Year | 10 | Month | 15 | Day |
2013 | Year | 10 | Month | 16 | Day |
2013 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014073
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |