UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022210 |
|---|---|
| Receipt number | R000025584 |
| 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 |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2022/05/10 09:12:49 |
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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
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
mniihara@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025584
