UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)
Title of the study (Brief title)	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	Masaki Nakamura
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama city, Wakayama, Japan
TEL	073-441-0613
Email	twins@wakayama-med.ac.jp

Public contact
Name of contact person	Masaki Nakamura
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 01 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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