UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002785 |
|---|---|
| Receipt number | R000003381 |
| Scientific Title | A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902) |
| Date of disclosure of the study information | 2009/11/19 |
| Last modified on | 2024/11/02 21:38:27 |
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Basic information
Public title
A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Acronym
A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Scientific Title
A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Scientific Title:Acronym
A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Region
| Japan |
Condition
Condition
advanced and/or metastatic gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility and effectiveness of TS-1 plus Docetaxel for aged patients with advanced and/or metastatic gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate (RECIST)
Key secondary outcomes
Adverse Events/Incidence of AE.
Overall survival
Progression Free Survival
Time to Treatment Failure
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
Docetaxel and TS-1 (DS):A course includes docetaxel 40 mg/m2 on day 1 and TS-1 80 mg/m2/day for 14 days followed by 7 days of interval. Patients undergo repeats of this 3 week therapy until diagnoses of PD and/or untolerable adverse events or patients request to stop.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric cancer
2) with measurable lesions for RECIST criteria
3) Patients older than 75 years
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5) Patients who can intake orally
6) Patients' labo data within normal range
WBC:Between 4,000/mm3 and 12,000/mm3
Neutrocyte:More than 2,000/mm3
Hb:More than 8.0g/dL
Platelet:More than 100,000/mm3
Total bil.:Less than 1.5mg/dL
AST(GOT)ALT(GPT):Less than 2.5 times of upper normal range
Ccr:More than 40 mL/min
7) Patients without any prior chemotherapy are eligible and patients without any adverse events due to prior chemotherapy completed before 6 months are also eligible.
8) A predicted life expectancy of at least 3 months.
9) Written informed consent to participate in this study.
Key exclusion criteria
1) Patients with active double cancers
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, uncontrolled DM, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Patients with ascites and/or pleural fluid
4) Patients with any symptoms due to metastases to the central nervous system
5) Patients with any fresh bleeding from digestive tract
6) with severe ischemic cardiac diseases or arythmia which needs treatments
7) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray and/or CT
8) History of serious drug hypersensitivity due to 5-FU, Docetaxel or Polysolbate 80
9) Patients with severe dysfunction of kidney, bone marrow and/or liver
10) Patients who need flucitosine, fenitoin or walfarin
11) Patients with untreated edema
12) Any other patient whom the physician in charge of the study judges to be unsuitable.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Imamura Hiroshi |
Organization
Toyonaka Municipal Hospital
Division name
Dpt.Surgery
Zip code
Address
4-14-1,Shibaharacho,Toyonaka, 560-8565
TEL
06-6843-0101
imamurahiroshisakai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Furukawa Hiroshi |
Organization
Kinki University Faculty of Medicen
Division name
Department of surgery
Zip code
Address
377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
imamurahiroshisakai@yahoo.co.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department
Personal name
Funding Source
Organization
NPO Osaka Chinical 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
市立堺病院(大阪府)、八尾市立病院(大阪府)、大阪労災病院(大阪府)、市立吹田市民病院(大阪府)、大阪医療センター(大阪府)、関西電力病院(大阪府)、ベルランド総合病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、箕面市立病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-023-02437-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-023-02437-4
Number of participants that the trial has enrolled
31
Results
The response rate was 45.2% (95% CI 27.3%-64.0%; p = 0.001) and it exceeded the expected response rate set at 40%. Median progression-free survival was 5.8 months, the 1-year survival rate was 58.1%, and the median survival time was 16.1 months.
Results date posted
| 2024 | Year | 11 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 16 | Day |
Baseline Characteristics
Patients aged 75 years or older with advanced gastric cancer were enrolled.
Participant flow
From February 2010 to January 2015, 31 patients were enrolled.
Adverse events
The major grade 3/4 adverse events were neutropenia (58%), febrile neutropenia (13%), anemia (10%), anorexia (10%), and fatigue (6%).
Outcome measures
The primary endpoint was overall response rate.
Plan to share IPD
.
IPD sharing Plan description
.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003381
