UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020815 |
|---|---|
| Receipt number | R000024030 |
| Scientific Title | A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2019/05/18 01:49:45 |
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Basic information
Public title
A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction
Acronym
ESOX trial
Scientific Title
A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction
Scientific Title:Acronym
ESOX trial
Region
| Japan |
Condition
Condition
adenocarcinoma of the esophagogastric junction
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
R0 rate
Key secondary outcomes
response rate, rate of the patients who completed the neoadjuvant treatment, pathological response rate, Perioperative complications rate, 2y recurrence free survivalrate, 3y recurrence free survival rate, overall survival, adverse event rate, severe adverse event rate
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
Three courses of S-1+oxaliplatin (L-OHP 130mg/m2 div 2h day1, S-1 80-120 mg/body p.o. day1 evening~day15 morning ) are given by 3-week interval, prior to the surgery.
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) Pathologically proven adenocarcinoma of the esophagus.
2) Siewert type I or typeII with esophageal invasion over 3 cm.
3) T3/T4a and/or lymph node-positive (over 1cm )
4) Eligible for surgery with curative intent.
5) no prior therapy
6) An age of over 20
7) An ECOG performance status of 0 or 1
8) Major organs are in normal conditions.
Hemoglobin => 8.0g/dL
neutrophil count => 1,500/mm3
Platelet count => 100,000/mm3
Serum bilirubin <= 2.0 mg/dL
AST, ALT <= 100 IU/L
Serum creatinine <= 1.3 mg/dL
Creatinine clearance (or estimated GFR) => 60mL/min
9) Written informed consent must be taken by patients
Key exclusion criteria
1) Active synchronous or metachronous malignancy, excepting for early stage cancers
2) Active infectious diseases
3) Uncontrollable HBV infection
4) Pregnant or lactation women, or women with the possibility of the pregnancy.
5) Severe mental disorders, neurological disease
6) under systemic steroid therapy
7) under treatment of flucytosine, phenytoin or warfarin potassium
8) Iodoallergy
9) Unstable angina, or myocardial infarction within 6 months.
10) Patients who are judged inappropriate for the entry into this study by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Cancer Institute Hospital
Division name
Esophageal Cancer Division
Zip code
1358550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL
03-3520-0111
masayuki.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ichimura |
Organization
Cancer Institute Hospital
Division name
Gastroenterological Chemotherapy Department
Zip code
1358550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL
03-3520-0111
Homepage URL
takashi.ichimura@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Gastroenterological Chemotherapy Department
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital, Gastroenterological Chemotherapy Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Cancer Institute Hospital of JFCR
KKR SAPPORO MEDICAL CENTER
Kyoto University Hospital
Shizuoka Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
Tel
03-3520-0111
med.shinsa@jfcr.or.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
がん研究会有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024030
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