Unique ID issued by UMIN | UMIN000004932 |
---|---|
Receipt number | R000005871 |
Scientific Title | A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06) |
Date of disclosure of the study information | 2011/03/01 |
Last modified on | 2019/04/20 22:12:33 |
A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06)
A phase II study of DCS chemotherapy for advanced gastric cancer with peritoneal metastasis(KUGC06)
A Phase II study of induction chemotherapy with docetaxel, S-1 and cisplatin (DCS) for advanced gastric cancer with peritoneal metastasis (KUGC06)
A phase II study of DCS chemotherapy for advanced gastric cancer with peritoneal metastasis(KUGC06)
Japan |
Gastric cancer with peritoneal metastasis
Gastroenterology | Surgery in general | Gastrointestinal surgery |
Malignancy
NO
To evaluate safety and efficacy of induction chemotherapy with Docetaxel+S-1+CDDP for gastric cancer with peritoneal metastasis
Safety,Efficacy
R0 resection ratio
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Chemotherapy+Surgery
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Pathologically confirmed gastric cancer
2)Gross or microscopic peritoneal metastasis confirmed by laparoscopy
3)No distant metastasis detected by CT or MRI
4)No previous treatment
5)Age between 20 and 75 years old
6ECOG 0 or 1
7)Capable of oral administration
8)Informed concent
9)Biology and biochemistry within normal limits
1)Active bleeding from the tumor
2)Paralysis of intestine or ileus
3)Diarrhea(watery stool)
4)Synchronous multicancer
5)Serous infection
6)Interstitial pneumonitis or fibroid lung
7)Ascites requiring control or peritoneal metastasis detected by CT
8)Uncontrollable diabetes mellitus
9)Uncontrollable hypertention, heart insufficiency, myocardial infarction within 6 months,uncontrolled arrhythmia or angina
10)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study
11)Patient who has experienced serious drug allergy in the past
12)Patient with severe phyciatric disease
13)Patient who requires continuous use of flucytosine, phenytoin
14)HBsAb positive
15)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
30
1st name | Yoshiharu |
Middle name | |
Last name | Sakai |
Graduate School of Medicine, Kyoto University
Department of Surgery
6068507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
075-366-7595
ysakai@kuhp.kyoto-u.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Okabe |
Graduate School of Medicine, Kyoto University
Department of Surgery
6068507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
075-366-7595
hokabe@kuhp.kyoto-u.ac.jp
Department of Surgery
Graduate School of Medicine, Kyoto University
Department of Surgery
Graduate School of Medicine, Kyoto University
Self funding
Kyoto University Ethics comittiee
Yohida Konoe-cho, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
京都大学医学部付属病院(京都府)
京都医療センター(京都府)
大阪赤十字病院(大阪府)
北野病院(大阪府)
天理よろづ相談所病院(奈良県)
2011 | Year | 03 | Month | 01 | Day |
https://link.springer.com/article/10.1245%2Fs10434-019-07229-7
Partially published
https://link.springer.com/article/10.1245%2Fs10434-019-07229-7
30
Among 30 enrolled patients, 24 completed three cycles of DCS. The most frequent grade 3 or 4 toxicity was neutropenia (60%). A complete response of peritoneal metastasis was observed in 16 patients, and 14 patients achieved R0 resection (47%; 95% confidence interval 28to66%). When the extent of peritoneal metastasis was classified as P0CY1, P1, P2, and P3 according to the Japanese classification, the R0 resection rates were respectively 63%, 60%, 46% and 0%.
2019 | Year | 04 | Month | 20 | Day |
2019 | Year | 02 | Month | 14 | Day |
No. of patients 30
Median age: years (range) 60 (42to73)
Sex
Male 15
Female 15
Performance status
0 23
1 7
Histology
Differentiated 6
Undifferentiated 24
Macroscopic types
1 1
2 3
3 9
4 16
5 1
T category
T3 (SS) 1
T4a (SE) 25
T4b (SI) 4
N category
N0 5
N1 7
N2 15
N3 3
CY category
CY0 8
CY1 19
CYX 3
P category
P0 8
P1 5
P2 13
P3 4
PC stages
0 8
1 3
2 13
3 6
4 0
All enrolled pts (n = 30)
Eligible (n = 29)
Induction CTX (n = 30)
Induction CTX
Ineligible (n = 1)
- Paraaortic lymph node metastasis
Incomplete CTX (n = 6)
- Severe adverse event (n = 1)
- Patient refusal (n = 2)
- Delayed recovery (n = 1)
completed (n = 24) - Other reasons (n = 2)
Surgery (n = 21)
Not operated (n = 9)
R0 resection (n = 14)* R1/2 resection (n = 7)
The most frequent grade 3 or 4 toxicity was neutropenia (60%).
A complete response of peritoneal
metastasis was observed in 16 patients, and 14 patients
achieved R0 resection (47%;95% confidence interval
28to66%).
Main results already published
2011 | Year | 01 | Month | 25 | Day |
2011 | Year | 04 | Month | 21 | Day |
2011 | Year | 06 | Month | 01 | Day |
2018 | Year | 04 | Month | 30 | Day |
2011 | Year | 01 | Month | 22 | Day |
2019 | Year | 04 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005871