UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023405 |
|---|---|
| Receipt number | R000026966 |
| Scientific Title | A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStageIII advanced gastric cancer patients |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2016/07/30 15:00:20 |
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Basic information
Public title
A phase II study of neoadjuvant
chemotherapy with S-1 and oxaliplatin
followed by surgery in cStageIII advanced
gastric cancer patients
Acronym
A phase II study of neoadjuvant
chemotherapy with S-1 and oxaliplatin
followed by surgery in cStageIII advanced
gastric cancer patients
Scientific Title
A phase II study of neoadjuvant
chemotherapy with S-1 and oxaliplatin
followed by surgery in cStageIII advanced
gastric cancer patients
Scientific Title:Acronym
A phase II study of neoadjuvant
chemotherapy with S-1 and oxaliplatin
followed by surgery in cStageIII advanced
gastric cancer patients
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of
perioperative SOX therapy in cStageIII
advanced gastric cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Percent completion of the protocol treatment
Key secondary outcomes
Overall survival, Relapse-Free Survival,
Time to Treatment Failure, Percent
completion of neoadjuvant chemotherapy,
Percent completion of adjuvant
chemotherapy, Response Rate, Pathological response rate, Incidence of adverse events on neoadjuvant chemotherapy, Incidence of a postoperative complication, The rate of R0 resection, Percent completion of the
protocol treatment in patients with over
75 years of age
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 | Maneuver |
Interventions/Control_1
S-1:80-120mg/body/day,PO,day1-14,Oxaliplatin130 mg/m2, IV day1, every 21 days for 3
cycles followed by surgery (laparoscopic or open gastrectomy, D2 lymph node dissection).Adjuvant chemotherapy(S-1) for one year
after surgery.
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) Histologically proven gastric
adenocarcinoma
2) Clinical Stage III gastric cancer
3) Age between 20 and 80 years old
4) ECOG performance status of 0 or 1
5) No previous chemotherapy,radiation
therapy or surgery for gastric cancer
6) Adequate organ function
1. WBC:>=3,000/mm3,<12,000/mm3
2. Neutrophil:>=1,500/mm3
3. Platelet:>=100,000/mm3
4. Hemoglobin:>=9.0g/dL
5. AST(GOT)/ALT(GPT):<=100 IU/L
6. Total bilirubin:<=2.0mg/dL
7. Serum creatinine:<=1.2mg
8. Creatinine clearance:>=60 mL/min
7) Possible oral intake
8) Written informed consent from patient
Key exclusion criteria
1) With active double or multiple cancers
2) Severe complications
3) With active infection
4) Positive HBs antigen or positive HCV
antibody
5) Continuous systemic steroid therapy
6) Severe diarrhea
7) Past history of severe hypersensitivity to drugs
8) Under treatment with flucytosine
9) Under treatment with warfarin
10) Pregnant women, or women with the
possibility of the pregnancy, Men who want let to pregnancy
11) Patients judged inappropriate for the study by the physicians
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Nakamura |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0613
twins@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Nakamura |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0613
Homepage URL
twins@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University,
Second Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 07 | Month | 31 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2016 | Year | 07 | Month | 30 | Day |
Last modified on
| 2016 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026966
