UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005877 |
|---|---|
| Receipt number | R000006858 |
| Scientific Title | Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2020/01/06 14:53:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer
Acronym
ECDN
Scientific Title
Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer
Scientific Title:Acronym
ECDN
Region
| Japan |
Condition
Condition
Advanced or recurrent esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
overall survival, one year survival rate, progression free survival, objective response rate, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NDP(80mg/m2) and DOC(60mg/m2) combination chemotherapy
Interventions/Control_2
DOC (70mg/m2) chemotherapy
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.recurreent esophageal cancer
2.the tumor has a measurable lesion for evaluation.
3.5FU/CDDP resistance
4.ECOG PS:0 to 2
5.Age from 20 to 80 years
6.Adequate organ function
WBC:>3,000/ mm3 <12,000/mm3
Neutro:>1,500/mm3
Hb:>9.0 g/dl
Plt:>100,000/mm3
T-Bil:<1.5mg / dl
AST(GOT),ALT(GPT):within 2.5 times the normal upper limits
Ccr: 1.5mg/dl
C.Cr:>50ml / min (Cockcroft- Gault)
7. Written informed consent
Key exclusion criteria
(1) patient who has drug allergy as past history
1. Known hypersensitivity to DOC, NDP and Polysorbate-80
2. patient who has active infectious disease
3. patient who has active double cancer
4. patient who has severe complication (interstitial pneumonitis, DM etc.)
5.concomitant treatment with steroids
6.EDEMA
7. patient who want to be pregnant and /or pregnant woman
8. patient who was judged to be unsuitable for this clinical trial
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Shimada |
Organization
Toho University School of Medicine
Division name
Department of Surgery
Zip code
181-0001
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL
0422577669
yajiman68@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yajima |
Organization
Division of General and Gastroenterological Surgery, Department of Surgery (Omori), Toho University
Division name
Department of Surgery
Zip code
143-8541
Address
6-11-1 Omori-nishi Ota-ku Tokyo Japan
TEL
0422577669
Homepage URL
yajiman68@yahoo.co.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
None
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
Toho Unoversity School of Medicine
Address
6-11-1 Omori-nishi Ota-ku Tokyo Japan
Tel
0337624151
yajiman68@yahoo.co.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
| 2011 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006858
