UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017652 |
|---|---|
| Receipt number | R000020456 |
| Scientific Title | A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2019/11/25 17:04:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
Acronym
A phase II study of preoperative DOS for cStage III gastric cancer
Scientific Title
A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
Scientific Title:Acronym
A phase II study of preoperative DOS for cStage III gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year progression-free survival
Key secondary outcomes
Overall survival, Progression-free survival, Response rate of preoperative chemotherapy, Pathological response rate, R0 resection rate, Proportion of adverse events.
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
preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1
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) Histological proven adenocarcinoma.
2) cStage III gastric or esophagogastric junction cancer.
3) Not Borrmann type 4 and not large (8cm or less) type 3.
4) Possible for R0 surgery.
5) No prior treatment of chemotherapy or radiation therapy and no history of surgery for gastric cancer.
6) No active gastrointestinal bleeding.
7) Possible oral intake or administration of adequate calories using an enteral feeding tube.
8) ECOG performance status of 0 or 1.
9) Aged 20 to 79 years old.
10) No prior treatment of chemotherapy, radiation or hormone therapy against any other malignancies.
11) No history of gastrectomy other than endoscopic mucosal resection.
12) Adequate organ function.
13) Written informed consent from patient.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Past history of severe hypersensitivity to drugs.
3) Active infection.
4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension)
5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
6) Edema of limbs and trunk by any reason.
7) Continuous systemic steroid therapy.
8) Under treatment with flucytosine, phenytoin, or warfarin.
9) Abnormal electrocardiogram or severe cardiovascular disease.
10) Severe diarrhea.
11) Positive HBs antigen.
12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Kurokawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Kurokawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8295
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2015 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
