Unique ID issued by UMIN | UMIN000006674 |
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Receipt number | R000007825 |
Scientific Title | A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer. |
Date of disclosure of the study information | 2011/11/08 |
Last modified on | 2017/05/10 12:04:17 |
A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.
NECESSIT study
A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.
NECESSIT study
Japan |
resectable advanced gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and tolerability of combination chemotherapy with TS-1, Cisplatin and Paclitaxel in resectable advanced gastric cancer.
Safety,Efficacy
Phase II
response rate
pathological complete response rate
recurrence-free survival time
progression-free survival
overall survival
proportion of transit surgery
proportion of R0 resection
Accomplishment rate
down stage rate
frequency and grade of adverse postoperative complication
frequency and grade of adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS-1 administered for 14 days followed by 7 days rest according to body surface area.
Cisplatin is administered intravenously in dosage of level at day 1 and day 8.
Paclitaxel is administered intravenously in dosage of level at day 1 and day 8.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histopathological confirmation of Adenocarcinoma
2) resectable advanced gastric cancer
3) measurable disease
4) Age over 20
5) ECOG performance status of 0 to 2
6) Sufficient function of important organs
Leu : ≥ 500 /mm3 and≤12,000 /mm3
Neu : ≥ 2,000 /mm3
Plate : ≥ 100,000 /mm3
hemoglobin : ≥ 9.0 g/dL
AST, ALT : <100 IU/L
St.bil : < 1.5 mg/dL
Ccr : ≥60 ml/min
7) Ability to ingestion intake and drug administration orally.
8) Informed consent is obtained.
1) With severe allergy to TS-1, Cisplatin and Paclitaxel
2) Women who are pregnant or breastfeeding.
3) Men who are unwilling to avoid pregnancy.
4) Active infection and inflammation.
5) History of cardiac disease
6) Dyspnea at rest
20
1st name | |
Middle name | |
Last name | Motohiro Imano |
Kinki University Faculty of Medicine
Department of Surgery
377-2 Ohnohigashi, Osakasayama Osaka
072-366-0221
imano@med.kindai.ac.jp
1st name | |
Middle name | |
Last name | Motohiro Imano |
Kinki University Faculty of Medicine
Department of Surgery
377-2 Ohnohigashi, Osakasayama Osaka
072-366-022
imano@med.kindai.ac.jp
Kinki University Faculty of Medicine
None
Self funding
NO
近畿大学医学部附属病院
2011 | Year | 11 | Month | 08 | Day |
Unpublished
Main results already published
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2022 | Year | 07 | Month | 01 | Day |
2011 | Year | 11 | Month | 05 | Day |
2017 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007825
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