UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003370 |
|---|---|
| Receipt number | R000004049 |
| Scientific Title | Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. |
| Date of disclosure of the study information | 2010/03/25 |
| Last modified on | 2014/06/18 11:19:30 |
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Basic information
Public title
Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Acronym
T4/M1LYM DCF PI/II study
Scientific Title
Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Scientific Title:Acronym
T4/M1LYM DCF PI/II study
Region
| Japan |
Condition
Condition
esophageal neoplasm
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and efficacy of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Complete response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
5-fluorouracil 700mg/m2/day day1-5 civ
cisplatin 70mg/m2/day day1
RT 60Gy/30fr/6w
q2w ,2cycle
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
| 70 | 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) radiologist permits curative radiotherapy 60Gy
4) with T4 tumors and/or distant lymph node metastasis (M1LYM)
5) no lymph nodes more distant than
the celiac region in the abdomen/no distant organ metastases
6) no esophagobronchial fistulas/no esophagomediastinal fistulas,
7) Aged 20 to 70 years old
8) ECOG PS of 0 or 1
9) no previous treatment of esophageal cancer without endoscopic resection
10) no previous chemotherapy or radiotherapy against any other malignancies
11) adequate organ functions
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 within three months
8) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
9) Active bacterial or fungous infection
Target sample size
30
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
0471331111
hsatake@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironaga SATAKE,MD |
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
078-302-4321
Homepage URL
hsatake@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
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
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
| 2010 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 24 | Day |
Last modified on
| 2014 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004049
