Unique ID issued by UMIN | UMIN000000714 |
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Receipt number | R000000849 |
Scientific Title | A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604) |
Date of disclosure of the study information | 2007/05/17 |
Last modified on | 2022/11/06 14:37:43 |
A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Japan |
Stage IIIA or stage IIIB gastric cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
A phase II study, that a combination of Docetaxel plus TS-1 is administered to patients with stage IIIA or stage IIIB gastric cancer, postoperatively, is carried out to confirm the feasibility or safety of the treatment.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
The ratio of the patients who completed the course
Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of
TS-1 in a year
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
DXT 40mg/m2 is administered by drip infusion on day 1.
TS-1 80 mg/m2/day is administered orally between day 1 and day 14.
It takes 21 days for the one course
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. histologically proven gastric carcinoma
2. D2 lymph node dissection and curative resection (R0) at the prior surgery
3. patients with stage IIIA or stage IIIB gastric cancer
4. age: 20<= and =<80 years old
5. PS(ECOG): 0 – 1
6. without any prior radiation therapy, chemotherapy, or hormone therapy
7. patients who can take medicine orally
8. without any other severe diseases
WBC 4,000<= and => 12,000/mm3
Neutrocyte 2,000mm3<=
Hemoglobin 9.0 g.dl <=
Platelet 100,000/mm3 <=
Total bilirubin 1.5 mg/dl =>
AST, ALT normal range in each institute
Serum creatinin 1.2 mg/dl >=
Creatinin clearance 60 ml/min/body <=
**Cockcroft-Gault method is available
9. written informed consents
1. with double cancer and/or multiple cancer
2. patients who cannot take TS-1
3. patients who need flucitosine, fenitoin or warfarin
4. with allergic history against medicines
5. with severe allergic response against polysolbate 80
6. without any disorder on the chest X-ray or CT, or interstitial
pneumonitis or pulmonary fibrosis
7. with other severe diseases (intestinal paralysis, intestinal obstruction, uncontrolled DM, cardiac failure, or liver dysfunction)
8. watery diarrhea
9. pregnant and/or nursing women
10. men who need their children in future
11. liver cirrhosis or active hepatitis
12. cavity fluid which should be taken out
13. doctors' stop not to register to the study
35
1st name | |
Middle name | |
Last name | Shigeyuki Tamura |
Kansai Rosai Hospital
Department of surgery
660-8511 3-1-69, Inabaso, Amagasaki-shi, Hyogo
06-6416-1221
1st name | |
Middle name | |
Last name | Hiroshi Furukawa |
Kinki University Faculty of Medicen
Department of surgery
377-2, Onohigashi, Osakasayama, Osaka, Japan
072-366-0221
OGSG
NPO Osaka Chinical Study Supporting Organization
Self funding
NO
2007 | Year | 05 | Month | 17 | Day |
https://link.springer.com/article/10.1007/s10120-013-0273-7
Published
http://link.springer.com/article/10.1007%2Fs10120-013-0273-7
53
The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %).
2022 | Year | 11 | Month | 06 | Day |
2013 | Year | 06 | Month | 05 | Day |
stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy
Fifty-three patients enrolled.
.
Three-year overall survival (OS)
Three-year disease-free survival (DFS)
Completed
2006 | Year | 10 | Month | 03 | Day |
2007 | Year | 05 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 12 | Month | 01 | Day |
2007 | Year | 05 | Month | 10 | Day |
2022 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000849
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