UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002181 |
|---|---|
| Receipt number | R000001829 |
| Scientific Title | A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801) |
| Date of disclosure of the study information | 2009/07/10 |
| Last modified on | 2022/11/06 14:17:33 |
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Basic information
Public title
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Acronym
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Scientific Title:Acronym
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Region
| Japan |
Condition
Condition
advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A feasibility on completion of four courses of S-1 and CPT-11 after gastric resection is evaluated to make the following phase III study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Patients ratio with 4 course completion
Key secondary outcomes
1.Patients ratio with one year course completion
2.Incidence of adverse events
3.Recurrence Free Survival
4. Overall Survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CPT-11 80mg/m2 is administered by drip infusion on day 1.
TS-1 (BSA<1.25 40mg/body/once,1.25<=BSA<1.5 50mg/body/once,BSA>=1.5 60mg/body/ once) is administered twice a day orally between day 1 and day 21.
It takes 35 days for the one course.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible criteria
1. primary gastric cancer diagnosed pathologically.
2. Final curability is B with D2 or D3 lymph node dissection
3. Stage IIIA(T2-N2,T3-N1 or T4-N0) or Stage IIIB(T3-N2 or T4-N1)
4. without any prior treatment for cancer
5. 4-8 weeks interval between surgical operation and following chemotherapy
6. age : 20-75 year old
7. performance status (ECOG):0-1
8. patients who can eat orally
9. without any severe disorder on the organs and with the data satisfied
the following criteria measured within 2 weeks of registration
1) WBC >=4,000/mm3 and <12,000mm3
2) Neutrocyte >=2,000/mm3
3) Platelet >=100,000/mm3
4) Hg >=8.0g.dl
5) T.bil <=1.5mg/dl
6) GOT, GPT <=100 IU/l
7) sCr <=1.2mg/dl
10. written informed consent
Key exclusion criteria
Ineligible criteria
1.A fresh bleeding on the digestive tract
2.Severe allergy against medicines or history of allergy
3.with active double cancer
4.with uncontrollable cavity fluid
5.with some infectious diseases and/or febrile condition
6.with brain metastases
7.with some disorders on ECG
8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction
9.with liver cirrhosis and/or active hepatitis
10.with DM uncontrollable
11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis
12.uncontrollable diarrhea
13.under intestinal paralysis or ileus
14.patients with psychological disorder who seems difficult to undergo treatment
15. under medication of ATAZANABIL
16. under continuous medication of steroids
17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin
18. pregnant and/or nursing women or patients who like to have children
19. patient who seems difficult to undergo protocol treatment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujitani Kazumasa |
Organization
National Hospital Organization Osaka National Hospital
Division name
Dpt. surgery
Zip code
Address
2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL
06-6942-1331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujitani Kazumasa |
Organization
National Hospital Organization Osaka National Hospital
Division name
Dpt. surgery
Zip code
Address
2-1-14,Houenzaka,Chuou-ku,Osaka,540-0006
TEL
06-6942-1331
Homepage URL
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
Osaka Clinical Study Supporting Organization
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
| 2009 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.karger.com/Article/Abstract/329090
Publication of results
Published
Result
URL related to results and publications
https://www.karger.com/Article/Abstract/329090
Number of participants that the trial has enrolled
53
Results
A total of 42 patients (79.2%, 95% CI 65.9-82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8-76.9) completed subsequent S-1 monotherapy for 1 year.
Results date posted
| 2022 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 18 | Day |
Baseline Characteristics
pathological stage III gastric cancer who underwent D2 gastrectomy
Participant flow
We enrolled 53 patients.
A total of 42 patients tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients completed subsequent S-1 monotherapy for 1 year.
Adverse events
Grade 4 neutropenia was observed in 28% and grade 3 febrile neutropenia in 9% of the patients, while grade 3 nonhematological toxicities were relatively low.
Outcome measures
tolerance of the planned 4 cycles of treatment with S-1 and docetaxel
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2008 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2008 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001829
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