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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020864
Receipt No. 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 2020/08/19

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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
Email 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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
Email

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 No longer recruiting
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
2020 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023978

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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