UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002396 |
|---|---|
| Receipt number | R000002888 |
| Scientific Title | Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma. |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2011/08/30 20:52:56 |
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Basic information
Public title
Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.
Acronym
neoadjuvant DCF for esophageal carcinoma
Scientific Title
Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.
Scientific Title:Acronym
neoadjuvant DCF for esophageal carcinoma
Region
| Japan |
Condition
Condition
esophageal neoplasm
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and efficacy of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil in patients with clinical stage II/III esophageal carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of treatment completion
Key secondary outcomes
Overall survival
Progression free survival
Resectability rate
Adverse event
Response rate
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
initial cohort n=30
aged 70 or younger
docetaxel 70 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 750 mg/m2/day day1-5 civ
q3w , 3 cycle
Esophagectomy with D2 (or more) lymph node desection
Interventions/Control_2
expanding cohort n=10
aged 75 or younger
docetaxel 75 mg/m2/day day1 iv
cisplatin 75 mg/m2/day day1 iv
5-fluorouracil 750 mg/m2/day day1-5 civ
q3w , 3 cycle
Esophagectomy with D2 (or more) lymph node desection
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage II or III without T4
4) Aged 20 to 75 years old
(expanding cohort ; aged 75 or younger)
5) ECOG PS of 0 or 1
6) no need for measurable lesion
7) no previous treatment of esophageal cancer
8) no previous chemotherapy or radiotherapy against any other malignancies
9) no palsy of recurrent nerve
10) adequate organ functions
11) curative resection for esophageal carcinoma
12) written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential
3) Psychosis
4) Patients requiring systemic steroids medication
5) HBs antigen positive
6) Uncontrollable diabetes millutus
7) History of myocardial infarction or unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
8) Active bacterial or fungous infection
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Tahara, MD, PhD |
Organization
National Cancer Center Hospital East
Division name
Division of Digestive Endoscopy and GI Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hara, MD |
Organization
Saitama Cancer Center
Division name
Department of Gastroenterology
Zip code
Address
818 Komuro, Ina, Saitama 362-0806, Japan
TEL
048-722-1111
Homepage URL
hirhara@cancer-c.pref.saitama.jp
Sponsor or person
Institute
Saitama Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for promotion of cancer research in Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
栃木県立がんセンター(栃木県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
大阪医科大学(大阪府)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=79240
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 28 | Day |
Last modified on
| 2011 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002888
