Unique ID issued by UMIN | C000000285 |
---|---|
Receipt number | R000000365 |
Scientific Title | Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1 |
Date of disclosure of the study information | 2005/11/18 |
Last modified on | 2009/09/14 16:19:00 |
Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1
Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1
Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1
Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1
Japan |
senior citizen's gastric cancer
Gastroenterology | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To examine a clinical effect and safety of the TS-1 administering to inoperable or recurrent senior citizen's gastric cancer by 75 years old or more.
Safety,Efficacy
Exploratory
Phase II
Response rate
TTF, OS, Safety, Home treatment period, home treatment rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS1: 50 or 80 or 100 or 120 mg/body/day, orally 28 days, every 6 weeks
75 | years-old | <= |
Not applicable |
Male and Female
1)With pathologically proven gastric cancer
2) With at least one measurable lesion (RECIST)
3) Age 75 years old or more
4) ECOG performance status<=2
5) Sufficient organ functions
6) No prior chemotherapy
7) Life expectancy estimated>=3 months
8) With written informed consent
9) Case who has understanding that can secure S-1 compliance enough
1.History of severe drug allergic reaction
2.Severe Bone marrow suppression,renal and liver function disturbance
3.Concomitant therapy with another anticancer drug or flucytocine
4.Marked pleural effusion or ascites
5.Symptomatic brain metastasis
6.Intestinal fresh hemorrhage
7.Active secondary cancer
8.Accompanied serious diseases
9.Severe Ischemic heart disease or Arrhythmia which requires treatment
10.Watery diarrhea
11.Decision as ineligible by principal investigator
30
1st name | |
Middle name | |
Last name | Minoru Kurihara |
The Tokyo cooperative Oncology Group
Director
1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan
1st name | |
Middle name | |
Last name |
The Tokyo cooperative Oncology Group
Secretariat
The Tokyo cooperative Oncology Group
The Tokyo cooperative Oncology Group
Self funding
NO
2005 | Year | 11 | Month | 18 | Day |
Published
http://www.springerlink.com:80/content/h0w03400l76922m8/?p=9636b082bb344721ae0e0bfc46bf95ff&pi=1
Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes.
Conclusions:
The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.
Completed
2004 | Year | 05 | Month | 21 | Day |
2004 | Year | 06 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2007 | Year | 11 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2005 | Year | 11 | Month | 18 | Day |
2009 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000365
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |