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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000285 |
Receipt No. | 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 |
Basic information | ||
Public title | Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1 |
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Acronym | Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1 |
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Scientific Title | Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1 |
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Scientific Title:Acronym | Searching research on senior citizen's gastric cancer on clinical effect and
safety of TS-1 |
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Region |
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Condition | ||||
Condition | senior citizen's gastric cancer | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | TTF, OS, Safety, Home treatment period, home treatment rate |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | TS1: 50 or 80 or 100 or 120 mg/body/day, orally 28 days, every 6 weeks | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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 |
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Key exclusion criteria | 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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The Tokyo cooperative Oncology Group | ||||||
Division name | Director | ||||||
Zip code | |||||||
Address | 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | The Tokyo cooperative Oncology Group | ||||||
Division name | Secretariat | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
Sponsor | |
Institute | The Tokyo cooperative Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | The Tokyo cooperative Oncology Group |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.springerlink.com:80/content/h0w03400l76922m8/?p=9636b082bb344721ae0e0bfc46bf95ff&pi=1 |
Number of participants that the trial has enrolled | |
Results | 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. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |