Unique ID issued by UMIN | UMIN000004734 |
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Receipt number | R000005633 |
Scientific Title | Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer |
Date of disclosure of the study information | 2010/12/20 |
Last modified on | 2015/04/21 08:38:44 |
Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP
Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP
Japan |
Stage III gastric cancer
Gastrointestinal surgery |
Malignancy
YES
Primary objective is to estimate the maximum tolerated dose (MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer.
Safety
estimate the maximum tolerated dose(MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest. At the second course, S-1 with CDDP adjuvant chemotherapy is conducted. S-1 is orally administered for 28 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) confirmed gastric cancer by endscopic biopsy
2) >=D2 lymph node dissection, R0 resection
3) Stage III
4) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology
5) age: >=20 and <80
6) possible to oral intake
7) No prior treatment except to surgery
8) sufficient function of important organs
9) written informed consent
1) with serious complications (intestinal paralysis, ileus, interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure etc)
with history of severe drug allergy
2) with clinically important infection
3) with diarrhea
4) with gastrointestinal bleeding need to repeat blood transfusion
5) with hepatocirrhosis or icterus
6) with clinically important mental disorder need to treat
7) with clinically important heart disease need to treat (ischemic heart disease, cardiac dysrhythmia etc)
8) with uncontrollable diabetes mellitus
9) pregnant or nursing women or women who like be pregnant and willing to get pregnant
10) doctor's decision not to be registered to this study
18
1st name | |
Middle name | |
Last name | Tsunehiro Takahashi |
School of Medicine, Keio University
Departent of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
1st name | |
Middle name | |
Last name | Tsunehiro Takahashi |
School of Medicine, Keio University
Departent of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
School of Medicine, Keio University
none
Self funding
NO
2010 | Year | 12 | Month | 20 | Day |
Published
Completed
2010 | Year | 04 | Month | 22 | Day |
2010 | Year | 07 | Month | 01 | Day |
2010 | Year | 12 | Month | 16 | Day |
2015 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005633
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