UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020864 |
|---|---|
| Receipt number | R000023978 |
| Scientific Title | Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G) |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2024/02/13 14:56:10 |
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Basic information
Public title
Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)
Acronym
Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)
Scientific Title
Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)
Scientific Title:Acronym
Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)
Region
| Japan |
Condition
Condition
advanced gastric cancer.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of S-1 + oxaliplatin compared with S-1 alone for elderly patients with advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression free survival,time to treatment failure,response rate,safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 monotherapy
S-1 was administered at 80mg/m2/BID (p.o.), on days 1-28 every 6 weeks until disease progression.
Interventions/Control_2
S-1 + oxaliplatin
S-1 plus oxaliplatin every 3 weeks until disease progression
S-1: 80mg/m2/BID (p.o.), on days 1-14
Oxaliplatin: 100mg/m2 (i.v.) on day 1
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric or gastro-esophageal junction adenocarcinoma
2) Advanced unresectable or recurrent gastric cancer
3) The criteria for pre-treatment
i. If there is no history of surgery
No previous chemotherapy, immunotherapy and radiation therapy for cancer. However, irradiation for the pain caused by bone metastases is allowed.
ii. If there is a history of surgery
No previous chemotherapy, immunotherapy and radiation therapy for cancer. However, irradiation for the pain caused by bone metastases is allowed.
a) Recurrence after radical surgery
Preoperative or postoperative adjuvant chemotherapy with S-1 alone is allowed.
More than 24 weeks (168 days) from the last date of the oral S-1 administration to recurrence
b) The palliative surgery for unresectable cases
More than two weeks after surgery
Postoperative complications has improved
Do not allow the neoadjuvant chemotherapy
c) Exploratory laparotomy, bypass surgery, etc. for unresectable cases.
4) Massive pericardial effusion, pleural effusion or ascites*.
*except for patients if effusions and ascites did no accumulate for more than two weeks after drainage therapy.
*include patients if pleurosclerosis was performed with anti-cancer drugs except OK-432.
5) Symptomatic brain metastases or carcinomatous meningitis.
6) Her2 negative
7) Measurable or evaluable lesion
8) adequate oral intake and able to take oral medication
9) 70 years old or older
10) ECOG performance status 0-2.
11) Adequate bone marrow and organ function as defined as below:
neutrophil count >=1500/mm3
hemoglobin level >= 8.0 g/dL
platelet count >= 100,000/mm3
AST and ALT <= 100 IU/L, or AST and ALT <=200 IU/L with liver metastases
total bilirubin <= 1.5 mg/dL
serum creatinine <=2.0 mg/dL
creatinine clearance >=30mL/min
12) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma.
2) Active infection under treatment
3) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0.
4) Diarrhea of grade >= 2 according to NCI-CTCAE version 4.0.
5) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray.
6) Receiving flucytosine
7) Receiving phenytoin or warfarin potassium
8) Current treatment with corticosteroids.
9) Pregnant or lactating female.
10) Uncontrolled psychiatry disease
11) History of serious allergic reactions.
12) Evidence of any other serious disease, e.g. COPD, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled cardiovascular disease, Cerebral infarction within one year, active gastrointestinal hemorrhage, blood tests positive for HBs antigen or HVC antibody.
13) Judged inappropriate by the investigators.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitaka Makiyama |
Organization
Japan Community Healthcare Organization Kyushu Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
1-8-1 kishinoura, yahatanishi-ku, Kitakyushu, Fukuoka 806-8501, Japan
TEL
093-641-5111
makiyama20@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 11 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023978
