UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000479 |
|---|---|
| Receipt number | R000000579 |
| Scientific Title | An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus |
| Date of disclosure of the study information | 2007/02/01 |
| Last modified on | 2009/09/02 15:09:18 |
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Basic information
Public title
An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus
Acronym
Prediction of chemoradiosensitivity with genetic profiling for esophageal squamous cell carcinoma
Scientific Title
An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus
Scientific Title:Acronym
Prediction of chemoradiosensitivity with genetic profiling for esophageal squamous cell carcinoma
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To search for chemoradiosensitivity related genes using a pretreatment biopsy sample and to establish an algorithm for prediction of chemoradiosensitivity in patients with esophageal squamous cell carcinoma
Basic objectives2
Others
Basic objectives -Others
Prediction of chemoradiosensitivity
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1 year disease free survival
Key secondary outcomes
1 year local disease free survival, 3 year disease free survival, 3 year over all survival, pathological complete response
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
CDDP 70mg/m2 day1, day 29,5-FU 700mg/m2 day 1-4, day 29-32+radiation 60Gy or CDDP 75mg/m2 day1, day 29, 5-FU 1000mg/m2 day 1-4, day 29-32+radiation 50.4Gy. Salvage surgery for nonCR case
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven squamous cell carcinoma of the thoracic esophagus 2) Clinical Stage IIa, IIb, III except T4 3) No previous history of chemotherapy nor radiotherapy 4) Above 20 years old and below 75 years old 5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6)Written informed consent obtained before treatment and esophageal biopsy 7) An essentially normal clinical laboratory profile (white blood cell count or WBC, >=4000/mm3; platelet count or Plt, >=100,000/mm3; hemoglobin or Hb >=10g/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT, =<100IU/l; total serum bilirubin=<1.5mg/dl; creatinin or Cr, =<1.2; creatinine clearance or CCr, >=60ml/minute; and saturated arterial oxygen or SpO2, 95% >= ECG, no abnormal findings or no need for treatment
Key exclusion criteria
1) Severe complication (heart failure, renal failure, hepatic failure, uncontrollable diabetes melitus) 2) Active bacterial infection 3) Previous radiotherapy for the chest 4)Interstitial Pneumonitis or pulmonary fibrosis 5) Tumor extend to the cervical esophagus or cardia of the stomach 6) Synchronous or metachronous malignancy 7) Multiple and different histological types of cancer 8) Pregnant female 9) Mental disease 10) Collagen disease (PSS, dermatomiositis ) 11) Tumor diameter, 8cm >= 12) Virus infection (HBV, HCV, PTHA, HIV)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Shimada MD |
Organization
University of Toyama
Division name
Department of Surgery & Science
Zip code
Address
930-0194 Sugitani 2630, Toyama, Japan
TEL
076-434-7331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Shimada MD |
Organization
University of Toyama
Division name
Department of Surgery & Science
Zip code
Address
930-0194 Sugitani 2630, Toyama, Japan
TEL
076-434-7331
Homepage URL
yshimada@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational Research Informatics Center,
Foundation for Biomedical Research and Innovation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
TRIEC0601
Org. issuing International ID_1
Translational Research Informatics Center,
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
富山大学病院（富山県）
愛知県立がんセンター（愛知県）
京都大学病院（京都府）
国立がんセンター中央病院（東京都）
国立がんセンター東病院（東京都）
近畿大学病院（大阪府）
群馬大学病院（群馬県）
鹿児島大学病院（鹿児島県）
川崎医科大学病院（岡山県）
九州がんセンター（福岡県）
琉球大学病院（沖縄県）
東京女子医大病院（東京都）
千葉大学病院（千葉県）
山形大学病院（山形県）
新潟大学病院（新潟県）
新潟がんセンター（新潟県）
大阪市立大学病院（大阪府）
国際福祉大学三田病院（東京都）
安佐市民病院（広島県）
岩手医科大学病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2006 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2006 | Year | 08 | Month | 29 | Day |
Last modified on
| 2009 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000579
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| Registered date | File name |
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