UMIN-CTR Clinical Trial

Basic information
Public title	A Phase I/II study of systemic chemotherapy with Docetaxel, Oxaliplatin, and S-1 followed by surgery in locally advanced adenocarcinoma of the esophagogostric junction
Acronym	A study of systemic chemotherapy with DOS followed by surgery in advanced AEG
Scientific Title	A Phase I/II study of systemic chemotherapy with Docetaxel, Oxaliplatin, and S-1 followed by surgery in locally advanced adenocarcinoma of the esophagogostric junction
Scientific Title:Acronym	A study of systemic chemotherapy with DOS followed by surgery in advanced AEG
Region	Japan

Condition
Condition	locally advanced adenocarcinoma of the esophagogastric junction
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase I part:To determine the recommended dose (RD) by estimating the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Docetaxel + Oxaliplatin + S1 (DOS) as a neoadjuvant chemotherpy for patients with locally advanced adenocaocinoma of the esophagogastric junction Phase II part:To evaluate the safety and efficacy of neoadjuvant chemotherapy with DOS the dose of which was recommended by the phase I part
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I:Occurrence rate of DLT at each dose level Phase II:R0 resection rate
Key secondary outcomes	Phase I:Occurrence rate of adverse events Phase II:3 year overall survival rate, 3 year relapse free survival rate, Completion rate of the protocol therapy, Response rate of neoadjuvant chemotherapy, Pathological responce of neoadjuvant chemotherapy, Rate of occurrence of adverse events

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 Maneuver
Interventions/Control_1	Neoadjuvant chemotherapy with DOS followed by surgical resection
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven adenocarcinoma by endoscopic biopsy 2) Tumor epicenter located within 5cm above or below the gastroesophageal junction determined by endoscopy or barium swallow 3) Clinical tumor depth of T3 or 4a determined by computed tomography and endoscopy 4) R0 resection or R1 resection solely by CY1 can be obtained 5) ECOG performance status of 0 or 1 6) No prior chemotherapy or radiotherapy for any cancer and no prior surgery for esophageal or gastric cancer 7) No severe organ dysfunction
Key exclusion criteria	1) Concurrent cancers 2) Pregnant or breast-feeding female. Male or female who wants to have children 3) Psychiatric disorders or severe psychiatric symptoms 4) Continuous use of systemic steroid 5) Positive for HBs antigen 6) Continuous use of flucytosine or phenytoin or warfarin 7) Severe drug allergy 8) Infectious disease or suspicion of infectious disease 9) Acute myocardial infarction within 6 months
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Hiki
Organization	Kitasato University School of Medicine
Division name	Department of Upper Gastrointestinal Surgery
Zip code	2520374
Address	1-15-1 Sagamihara Kanagawa Japan
TEL	042-778-8111
Email	nhiki@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Niihara
Organization	Kitasato University School of Medicine
Division name	Department of Upper Gastrointestinal Surgery
Zip code	2520374
Address	1-15-1 Sagamihara Kanagawa Japan
TEL	042-778-8111
Homepage URL
Email	mniihara@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Research Ethics Committee of the Kitasato University School of Medicine
Address	1-15-1 Kitasato, Sagamihara, Japan
Tel	0427788111
Email	rinrib@med.kitasato-u.ac.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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 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	2016 Year 04 Month 25 Day
Date of IRB	2016 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2022 Year 12 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	2016 Year 05 Month 05 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025584