UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004440 |
|---|---|
| Receipt number | R000005298 |
| Scientific Title | A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002) |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2022/11/06 12:23:44 |
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Basic information
Public title
A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Acronym
A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title
A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Scientific Title:Acronym
A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The durability and feasibility of 6 months continuous DTX+TS-1 administration after R0 gastrectomy is detected in the patients with Stage lllA/lllB gastric ccancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
six months durability rate of TS-1 administration
Key secondary outcomes
Overall survival,
Deasease-free survival,
Advers events,
Twelve months durability of TS-1 administration
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
| Medicine |
Interventions/Control_1
DTX and TS-1 are administrated 45 days after R0 operation.
One course includes
Docetaxel 40mg/m2 on day 1 + TS-1 80mg/m2 between day 1 and day 14, and 7 days rest.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)gastric cancer proven histologically
2)Patients who underwent D2 lymph node dissection to be curative operation
3)gastric cancer in Stage lllA or lllB by the japanese Classification pf Gastric Carcinoma(The 13th Edition)
4)patients older than 20 y.o. and younger than 80 y.o.
5)PS(ECOG)=0-1
6)without any treatment before(radiation therapy, Chemotherapy and/or hormone therapy)
7)patients who can take mesicine orally
8)without any severe complications and limited in the following date
WBC : 3,000/mm3<= and >=12,000/mm3
Neutrophile : 2,000/mm3
Hemoglobin : 9.0g/dl<=
Platelet : 100,000/mm3
T.bil. : 1.5mg/dl>=
AST,ALT : 100IU/L>=
creatinine : 1.2mg/dl
9)with written Informed Consent
Key exclusion criteria
1)Patients with double cancers (simultaneous or different time)
Following cases are eligeble :
1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma
2.small multiple cancers whose stages are lower than main cancer
3.double early cancers removed by EMR/EDS
2)patients who has contraindication to TS-1
3)patients who need Flucitosine,Fenitoin and/or Walfarin
4)patients who have a history of severe allergy against medicine in grade 3 or 4
5)patients who have a history of severe allergy against medicine including polysolvate 80
6)with interstitial pneumonia
7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction)
8)with watery diarrhea
9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future
10)Males who have a plan to have their own baby
11)with HIV (positive) or liver cirrhosis/active hepatitis
12)Edema which needs treatment
13)patients whom doctor in chief decides not to register to this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujitani Kazumasa |
Organization
Osaka General Medical Center
Division name
surgery
Zip code
Address
3-1-56, Bandaihigashi, Suniyosi-ku, Osaka-City
TEL
06-6692-1201
fujitani@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Furukawa |
Organization
Kinki University School of Medicine
Division name
Department of surgery
Zip code
Address
377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
hiroshi.furukawa@tokushukai.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
Osaka Clinical Study Support 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
NTT西日本大阪病院（大阪府）、八尾市立病院（大阪府）、市立堺病院（大阪府）、大阪医療センター（大阪府）、市立豊中病院（大阪府）、箕面市立病院（大阪府）、関西労災病院（兵庫県）、北野病院（大阪府）、西宮市立中央病院（兵庫県）、大阪府立急性期総合医療センター（大阪府）、大阪北逓信病院（大阪府）、阪南中央病院（大阪府）、土庫病院（奈良県）、市立貝塚病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10120-019-01023-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10120-019-01023-w
Number of participants that the trial has enrolled
62
Results
The completion rate for eight cycles of S-1 plus docetaxel(DS) therapy was 77.4% [95% confidence interval (CI) 65.0-87.1%]. Subsequent S-1 monotherapy for 1 year was feasible in 71.0% (95% CI 58.1-81.8%) of patients.
Results date posted
| 2022 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
stage III gastric cancer(GC)
Participant flow
Sixty-two patients with stage III GC were enrolled.
Adverse events
The incidence of neutropenia, leukopenia, anorexia and fatigue of grade 3 or higher was 10% or higher.
Outcome measures
The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who completed eight cycles of DS therapy.
The secondary endpoints were safety, disease-free survival (DFS), OS, and feasibility of S-1 administration until 1 year after surgery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 25 | 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=R000005298
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