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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002137
Receipt No. R000002555
Scientific Title PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.
Date of disclosure of the study information 2009/08/01
Last modified on 2012/01/05

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Basic information
Public title PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.
Acronym PhaseI/II trial of neoadjvant chemoradiotherapy with DCF in patients with advanced esophageal cancer.
Scientific Title PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.
Scientific Title:Acronym PhaseI/II trial of neoadjvant chemoradiotherapy with DCF in patients with advanced esophageal cancer.
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part: to evaluate maximum tolerated dose and dose-limiting toxicities to determine recommended dose of docetaxel in combination with a fixed dose of cisplatin and 5-FU and radiotherapy follwed by surgery in patients with advanesd esophageal cancer.
Phase II part: to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy with docetaxel, cisplatin and 5-FU follwed by surgery in patients with advanced esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes PhaseI:Incidence of dose limiting toxicity
PhaseII:Histopathological response rate
Key secondary outcomes PhaseI:Adverse events,Histopathological response rate
PhaseII:Adverse events, Disease-free survival, Overall survival

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 Device,equipment Maneuver
Interventions/Control_1 Radiotherapy(2Gy/5day/week) is begun within 24 hours of the administration of chemotherapy, and continue for 4 weeks(40Gy).
Combination chemotherapy consists of docetaxel (25,30,35,40 mg/m2/day, day 1,15,29 and day 43), cisplatin (70 mg/m2/day, day 1,29), and 5-FU (700mg/m2/day, days 1 through 4 and days 29-32).
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 esophageal carcinoma.
2.Lesion located within the radiation field.
3.Primary lesion with penetration of muscularis propiria, excluding T4 lesion and distant metastasis.
4.Measurable lesion
5.No previous therapy against esophageal cancer.
6.No previous radiotherapy within the radiation field.
7.ECOG Performance status 0 or 1
8.Aged 20 to 75 years old
9.Expected to survive more than 3 months
10.Written informed consent
Key exclusion criteria 1.History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80
2.With severe complication
3.Infection with fever elevation
4.Motor paralysis, peripheral neuropathy or edema
5.Pleural or pericardial effusion that requires treatment
6.Simultaneous or metachronous (within 5 years) double cancers.
7.Pregnant or lactating women
8.Interstitial pneumonia or fibroid lung
9.Psychosis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Research Institute for Radiation Biology and Medicine Hirosima University
Division name Surgical Oncology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima 734-0037 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name jun Hihara, Manabu Emi
Organization Research Institute for Radiation Biology and Medicine Hirosima University
Division name Surgical Oncology
Zip code
Address
TEL
Homepage URL
Email moaista@wish.ocn.ne.jp

Sponsor
Institute Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department

Funding Source
Organization Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
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
Email

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
2009 Year 08 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
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2014 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 06 Month 29 Day
Last modified on
2012 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002555

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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