UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer
Acronym	UDON P-II
Scientific Title	Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer
Scientific Title:Acronym	UDON P-II
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the effectiveness of the 5FU/ docetaxel / nedaplatin combination therapy for the esophageal cancer that radical radiation therapy is impossible having a recurrence case or remote metastasis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	progression free survival overall survival adverse event

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	Combination chemotherapy consists of docetaxel (35 mg/m2/day, day 1 and day 15), nedaplatin (90 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Primary tumor located at cervical esophagus, thoracic esophagus or esophago-gastric junction. 2)Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, adenocarcinoma or basaloid carcinoma. 3)Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy. a)In case of unresectable esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases ii)cT1-cT4a iii)Dysphagia score =<2 and no stenosis which endoscope does not pass through b)In case of recurrent esophageal cancer, all of the following conditions must be fulfilled: i)Having metastatic lesion except for #102 or #104 metastases. ii)Dysphagia score =<2. 4)Older than 20 years old. 5)ECOG PS of 0,1 or 2. 6)Measurable lesion is required. 7)Neither previous chemotherapy ,chemoradiotherapy,nor radiotherapy against any cancer 8)Adequate organ function 9)Without symptomatic brain metastasis 10)Without moderate or more ascites/pleural effusion 11)Written informed consent
Key exclusion criteria	1)Poorly controlled diabetes mellitus or routine administration of insulin. 2)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 3)History of hypersensitivity to 5FU, DOC, CDGP, or polysorbate 80. 4)Active infection requiring systemic therapy. 5)Patients requiring systemic steroid medication. 6)Motor paralysis or peripheral neuropathy by any reason. 7)Edema by any reason. 8)Severe pulmonary fibrosis or emphysema. 9)A case with the past of radiotherapy or the chemotherapy within two weeks before registration. 10)With moderate or more ascites/pleural effusion or pericardial fluid. 11) Severe cardiac disease , or with a history of myocardial infarction within 6 months , or poorly controlled hypertension. 12)A case to have the past of the cerebrovascular disorder that developed within six months. 13)A case to have diarrhea continuously. 14)Case having the intestinal tract paralysis, ileus 15)Positive HBs antigen , or positive HIV antibody. 16)The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 17) During the pregnancy or a pregnant female patient we are possible or are nursing.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name HIROTO UEDA
Organization	Kinki university Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2,ohnohigashi,osakasayamashi,osaka
TEL	072-366-0221
Email	h-ueda@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name HIROTO UEDA
Organization	Kinki University Faculty of Medicine
Division name	Department of Medical Oncology
Zip code
Address	377-2,ohnohigashi,osakasayamashi,osaka
TEL	072-366-0221
Homepage URL
Email	h-ueda@med.kindai.ac.jp

Sponsor
Institute	Kinki university Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2015 Year 05 Month 27 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	2014 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date	2014 Year 12 Month 09 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 26 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019570

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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