UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030909 |
|---|---|
| Receipt number | 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 15:13:22 |
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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
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
twins@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035291
