Unique ID issued by UMIN | UMIN000004578 |
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Receipt number | R000005467 |
Scientific Title | Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer. |
Date of disclosure of the study information | 2010/12/01 |
Last modified on | 2017/07/04 09:26:39 |
Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.
Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.(JFMC43-1003)
Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.
Randomized phase II study of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.(JFMC43-1003)
Japan |
Advanced or recurrent gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate clinical usefulness of daily administrations versus alternate-day administrations of TS-1 in advanced or recurrent gastric cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Progression Free Survival
Safety, Overall Survival, Time to Treatment Failure, Disease Control Rate and Response Rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Daily administrations: TS-1 is administered orally for 28 days, followed by 14 days rest.
Alternate-day administrations: TS-1 is administered orally at Monday, Wednesday, Friday and Sunday.
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma.
2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
3) No prior radiotherapy, chemotherapy or hormone therapy.
4) Adequate organ functions:
i) WBC >=3000/mm3 and <=12000/mm3,
ii) neutrophils >=2000/mm3,
iii) platelets >=100,000/mm3,
iv) hemoglobin >=8.0g/dL,
v) total bilirubin <=1.5mg/dL,
vi) AST(GOT)/ALT(GPT) <=100IU/L,
vii) creatinine clearance >=50mL/min.
5) ECOG Performance status:0-2
6) Expected survival over 3 months.
7) Age of 20 years or older.
8) Sufficient oral intake.
9) Normal ECG.
10) Written informed consent.
1) Limitation of use of TS-1.
2) Infection and inflammation.
3) Serious heart disease.
4) Symptomatic pulmonary fibrosis or interstitial pneumonia.
5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis.
6) A large amount of pleural effusion or peritoneal fluid.
7) Widespread bone-marrow metastases.
8) Brain metastasis.
9) Fresh bleeding from digestive organs.
10) Diarrhea.
11) Severe mental disorders.
12) Active synchronous malignancy.
13) Patients under treatment with flucytosine, phenytoin or warfarin potassium.
14) Pregnant females, possibly pregnant
females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
15) Other patients who are unfit for the study as determined by the attending physician.
120
1st name | |
Middle name | |
Last name | Hirakawa Kosei |
Osaka City University Graduate School of Medicine
Department of Surgical Oncology
1-4-3 Asahimachi, Abeno-ku, Osaka City ,Osaka 545-8585 JAPAN
06-6645-3838
1st name | |
Middle name | |
Last name | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Japanese Foundation for Multidisciplinary Treatment of Cancer
Office
1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
03-5627-7594
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Japanese Foundation for Multidisciplinary Treatment of Cancer
Japanese Foundation for Multidisciplinary Treatment of Cancer
Non profit foundation
Japan
NO
2010 | Year | 12 | Month | 01 | Day |
Published
http://dx.doi.org/10.1007/s10147-017-1157-3
Completed
2010 | Year | 07 | Month | 26 | Day |
2010 | Year | 12 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
2010 | Year | 11 | Month | 17 | Day |
2017 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005467
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