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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000000479
Receipt No. 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

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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
Email

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
Email yshimada@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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