UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015788 |
|---|---|
| Receipt number | R000018360 |
| Scientific Title | Randomized Phase II Study Comparing 2 versus 3 Cycles of Neo-adjuvant Chemotherapy (Docetaxel+CDDP+5FU) for Patients with Resectable Advanced Esophageal Cancer |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2014/11/29 13:28:59 |
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Basic information
Public title
Randomized Phase II Study Comparing 2 versus 3 Cycles of Neo-adjuvant Chemotherapy (Docetaxel+CDDP+5FU) for Patients with Resectable Advanced Esophageal Cancer
Acronym
2 versus 3 Cycle of Neo-adjuvant Chemotherapy for Esophageal Cancer
Scientific Title
Randomized Phase II Study Comparing 2 versus 3 Cycles of Neo-adjuvant Chemotherapy (Docetaxel+CDDP+5FU) for Patients with Resectable Advanced Esophageal Cancer
Scientific Title:Acronym
2 versus 3 Cycle of Neo-adjuvant Chemotherapy for Esophageal Cancer
Region
| Japan |
Condition
Condition
Resectable Advanced Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility of 2 or 3 cycle neo-adjuvant chemotherapy (Docetaxel+CDDP+5FU) for patients with resectable advanced esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year progression-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
2 cycles of neo-adjuvant chemotherapy (Docetaxel+CDDP+5FU)
Interventions/Control_2
3 cycles of neo-adjuvant chemotherapy (Docetaxel+CDDP+5FU)
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)histologically-proven thoracic esophageal squamous cell carcinoma with no prior treatment
2)cT1-4a with no distant metastases (UICC stageIB-IV)(including cases with metastases of supraclavicularlymph nodes)
3)age of 20 and older
4)ECOG Performance status 0-2
5)no prior treatment for esophageal cancer
6)normal function of primary organs
blood WBC 3000-12000/mm3
neotrophil >1500/mm3
platelet 100,000/mm3
hemoglobin >9g/dl
liver T-bil <1.5mg/dl
kidney CCr>60 (eitherCockcroft-Gault or actual measurement value)
lung room air Sop2>95
7)operable case via thoracotomy and laparotomy
8)cases with informed consent
Key exclusion criteria
1)inoperable case due to dysfunction of primary organs (brain, heart, lung, liver, kidney)
2)cases with active double cancer
3)cases with serious drug sensitivity and its history
4)female during pregnancy or lactation
5)inappropriate cases determined by primary doctor
6)cases with mental disorder enough to be unable to understand context of the present study
7)cases who have underwent cisplatin-based chemotherapy
8)cases with positivity of HBs antigen
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takushi Yasuda |
Organization
Department of surgery, Kindai univerisity
Division name
Department of upper GI surgery
Zip code
Address
377-2 Ono-higashi Osaka-sayamashi, Osaka, Japan
TEL
072-366-0221
tyasuda@surg.med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Shiraishi |
Organization
Department of surgery, Kindai univerisity
Division name
Department of upper GI surgery
Zip code
Address
377-2 Ono-higashi Osaka-sayamashi, Osaka, Japan
TEL
072-366-0221
Homepage URL
shiro@surg.med.kindai.ac.jp
Sponsor or person
Institute
Department of surgery, Kindai univerisity
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 26 | 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
| 2014 | Year | 11 | Month | 29 | Day |
Last modified on
| 2014 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018360
