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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016788
Receipt No. R000019459
Scientific Title Phase I/II trial of combined chemotherapy of S-1, Nab-paclitaxel and Oxaliplatin administered bi-weekly for patients with advanced gastric cancer(HGCSG1404: SNOW study)
Date of disclosure of the study information 2015/03/16
Last modified on 2019/10/06

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Basic information
Public title Phase I/II trial of combined chemotherapy of S-1, Nab-paclitaxel and Oxaliplatin administered bi-weekly for patients with advanced gastric cancer(HGCSG1404: SNOW study)
Acronym HGCSG1404: SNOW study
Scientific Title Phase I/II trial of combined chemotherapy of S-1, Nab-paclitaxel and Oxaliplatin administered bi-weekly for patients with advanced gastric cancer(HGCSG1404: SNOW study)
Scientific Title:Acronym HGCSG1404: SNOW study
Region
Japan

Condition
Condition advanced / reccurent gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase 1: To determine the maximum-tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) of SNOW regimen
Phase 2: To examine the efficacy and safety in the recommended dose
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes phase 1: MTD, RD
Key secondary outcomes phase 1: response rate, adverse events, pharmacokinetics
phase 2: safety, progression free survival, duration of disease control, overall survival, time to treatment failure, expression of SPARC

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1, nab-paclitaxel, oxaliplatin
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically proven adenocarcinoma of the advanced or recurrent gastric cancer
2. HER2 negative (or untested)
3. With measurable disease (RECIST v1.1)
4. No prior chemotherapy or radiation therapy (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for S-1 therapy)
5. age >=20 years
6. ECOG PS 0 or 1
7. Ingestible
8. Hematological status: neutrophils (ANC)>=1.5x109/L; platelets >=100x109/L; haemoglobin >=8g/dL, Adequate renal function: serum creatinine level >=1.2mg/dl,Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 x upper normal limit (ULN), AST/ALT<=100 U/L
9. Expected life span >= 3 months
10.Signed and dated informed consent
Key exclusion criteria 1. History of hypersensitivity to nab-paclitaxel, oxaliplatin, S-1
2. Contraindication to nab-paclitaxel, oxaliplatin, S-1
3. Infectious disease
4. HBs-antigen positive
5. Severe complication
6. Neuropathy with symptoms
7. Brain metastasis with clinical symptoms
8. Watery diarea.
9. Active double cancer
10. Persons to be pregnant or to make pregnant
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshito
Middle name
Last name Komatsu
Organization Hokkaido University Hospital
Division name Division of Cancer Center
Zip code 060-8648
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Kawamoto
Organization Hokkaido University Hospital
Division name Department of Gastoenterology and Hepatology
Zip code 060-8648
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Homepage URL
Email y-kawamoto0716@hotmail.co.jp

Sponsor
Institute NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

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 Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
Tel 0117065657
Email ykomatsu@ac.cyberhome.ne.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 北海道大学病院(北海道)、他

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 16 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
2015 Year 08 Month 28 Day
Date of IRB
2014 Year 11 Month 13 Day
Anticipated trial start date
2015 Year 11 Month 13 Day
Last follow-up date
2021 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 03 Month 12 Day
Last modified on
2019 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019459

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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