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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030909
Receipt No. R000035291
Scientific Title Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)
Date of disclosure of the study information 2018/01/20
Last modified on 2018/01/20

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Basic information
Public title Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)
Acronym NSOX study
Scientific Title Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)
Scientific Title:Acronym NSOX study
Region
Japan

Condition
Condition gastric cancer with peritoneal metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase 1: To determine the maxim um-tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) of NSOX 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 I: DLT
Phase II: The rate of negative conversion in P1
Key secondary outcomes Phase 1: MTD, RD, adverse events, pharmacokinetics
Phase 2: completion rate of treatment, response rate, curative resection rate, postoperative complication, pathological response rate, progression free survival, duration of disease control, recurrent free survival after gastrectomy, overall survival, time to treatment failure

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 nab-paclitaxel,S-1, 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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically proven adenocarcinoma of gastric cancer and positive peritoneal dissemination by staging laparoscopy
2. HER2 negative (or untested)
3. No non-curable factors except peritoneal dissemination
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, 75>= years
6. ECOG PS 0 or 1
7. Ingestible
8. Hematological status: neutrophils (ANC)>=1,500 /mm3; platelets >=100,000 /mm3; haemoglobin >=8g/dL, Adequate renal function: serum creatinine level <=1.2mg/dl,Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 xupper 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, S-1, oxaliplatin
2. Contraindication to nab-paclitaxel, S-1, oxaliplatin
3. Infectious disease
4. HBs-antigen positive
5. Severe complication
6. Neuropathy with symptoms
7. Brain metastasis with clinical symptoms
8. Watery diarrhea.
9. Active double cancer
10. Persons to be pregnant or to make pregnant
11. Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Nakamura
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-441-0613
Email twins@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Nakamura
Organization Wakayama Medical University, School of Medicine
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL 073-441-0613
Homepage URL
Email twins@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization Wakayama Medical University, School of Medicine
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
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 和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 20 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
2018 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 20 Day
Last modified on
2018 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035291

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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