Unique ID issued by UMIN | UMIN000015631 |
---|---|
Receipt number | R000018147 |
Scientific Title | A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402) |
Date of disclosure of the study information | 2014/11/10 |
Last modified on | 2021/11/27 18:09:48 |
A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Japan |
large type 3 or type 4 gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To confirm the efficacy and safety of preoperative TS-1+CDDP+DTX therapy (DCS therapy) and followed curative surgical operation for large type 3 or type 4 gastric cancer
Safety,Efficacy
Phase II
incidence of curative resection (R0 ratio)
Preoperative treatment completion rate
Postoperative treatment completion rate
Disease Free Survival
Overall Survival (OS)
Response Rate of preoperative chemotherapy
(RECIST v 1.1)
Histological Response Rate of preoperative
Chemotherapy
AE rate of preoperative chemotherapy Incidence of postoperative adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
It takes four weeks for one course of DCS therapy (DTX 40 mg/m2 iv day 1, CDDP 60 mg/m2 iv day 1 and TS-1 80-120 mg/body day 1-14, followed by 2 weeks rest)
Standard treatment is two or three courses before surgical operation
Patients undergo surgical operation within 42 days of completion of 2-3 courses
After R0 surgical operation, one year TS-1 administration is followed.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)histologically proven gastric carcinoma by endoscopic detection
2)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT within 28 days before registration
3)Without any P2, P3, liver metastases and/or paraaortic node metastases by CT, PET and/or laparoscopic detection within 28 days before registration
4)Without esophageal invasion longer than 3 cm by endoscopic detection within 28 days before registration
5)Age older than 20 years and younger than 75 years
6)Performance Status(ECOG): 0 or 1
7)Without any history of chemotherapy, radiation therapy and/or surgical operation for the gastric cancer
8)with good functions of important organs by a data taken within 2 weeks
of registration
a) WBC: =>4000/mm3 and <12,000 mm3
b) Neutrophil: =>1,500/mm3
c) Hemoglobin: =>8.0 g/dl
d) Platelet: =>100,000/mm3
e) AST: =< 100 IU/L
f) ALT: =< 100 IU/L
g) T.bil.: =<1.5 mg/dL
h) s-cleatinine: =<1.2mg/dL
i) creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available: => 60mL/min
9)enough oral intake
10)with written Informed Consent
1)with active double cancers excluding carcinoma in situ and/or prior
cancer cured with longer than 5 year interval period
2)with a history of severe allergic reaction against medicines
3)with active infectious diseases (over 38 centigrade of body temperature)
4)pregnant or nursing female
5)male expecting pregnancy of partner
6)with a history of cardiac infarction within 6 months
7)under continuous steroids medication
8)under continuous medication of phenytoin or warfarin
9)with uncontrollable diarrhea (frequent movement and/or watery stool)
10)with HBs antigen positive or HCV antibody positive
11)With severe diseases (collagen disease, intestinal paralysis, interstitial pneumonitis, and/or ischemic cardiac disease)
12)Any other patients whom the physician in charge of the study judges to
be unsuitable
45
1st name | |
Middle name | |
Last name | Kazumasa Fujitani |
Osaka General Medical Center
Department of Surgery
3-1-56, Bandaihigashi, Sumiyosi-ku, Osaka-City, 558-8558, Japan
06-6692-1201
fujitani@gh.opho.jp
1st name | |
Middle name | |
Last name | Jyunji Kawada |
Kaizuka City Hospital
Department of Surgery
3-10-20, Hori, Kaizuka-City, Osaka Prefecture, 597-0015, Japan
072-422-5865
j-kawada@umin.ac.jp
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
(OGSG 参加施設)
大阪医科大学(大阪府)、大阪労災病院(大阪府)、市立貝塚病院(大阪府)、大阪急性期・総合医療センター(大阪府)、市立池田病院(大阪府)、箕面市立病院(大阪府)、市立豊中病院(大阪府)、北野病院(大阪府)、関西労災病院(兵庫県)、関西電力病院(大阪府)、八尾市立病院(大阪府)、市立東大阪医療センター(大阪府)
2014 | Year | 11 | Month | 10 | Day |
Unpublished
48
Completed
2014 | Year | 10 | Month | 04 | Day |
2014 | Year | 11 | Month | 26 | Day |
2015 | Year | 03 | Month | 16 | Day |
2021 | Year | 06 | Month | 24 | Day |
2021 | Year | 09 | Month | 27 | Day |
Registered with JRCT on 26/03/2019
Certification number: CRB5200005
Trial ID: jRCTs051180195
2014 | Year | 11 | Month | 07 | Day |
2021 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018147
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |