UMIN-CTR Clinical Trial

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 Morihito Middle name Last name Okada
Organization	Research Institute for Radiation Biology and Medicine Hirosima University
Division name	Surgical Oncology
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima 734-8551 Japan
TEL	082-257-5869
Email	morihito1217@gmail.com

Public contact
Name of contact person	1st name Manabu Middle name Last name Emi
Organization	Research Institute for Radiation Biology and Medicine Hirosima University
Division name	Surgical Oncology
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima 734-8551 Japan
TEL	082-257-5869
Homepage URL
Email	moaista@hotmail.com

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	Hiroshima University hospital Center of Integrated Medical Research
Address	Kasumi 1-2-3, Minami-Ku, Hiroshima 734-8553, Japan
Tel	082-257-1752
Email	protocol@cimr.hiroshima-u.ac.jp

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	Completed
Date of protocol fixation	2009 Year 06 Month 01 Day
Date of IRB	2009 Year 09 Month 07 Day
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	2020 Year 03 Month 19 Day

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