UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma
Acronym	A phase II study of mDNF-R followed by S-1 maintenance therapy and salvage therapy for patients with esophageal carcinoma
Scientific Title	A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma
Scientific Title:Acronym	A phase II study of mDNF-R followed by S-1 maintenance therapy and salvage therapy for patients with esophageal carcinoma
Region	Japan

Condition
Condition	Esophageal carcinoma
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) To confirm the efficacy and safety of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation followed by S-1 maintenance therapy (2) To confirm the safety of salvage therapy for patients with recurrent lesion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1-year progression free survival
Key secondary outcomes	Overall survival Safety Radiation related adverse events Salvage therapy related adverse events Response rate Completion rate for S-1 maintenance therapy

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
Interventions/Control_1	Definitive chemoradiation therapy using docetaxel, nedaplatin and 5-fluorouracil (DNF) with concurrent radiotherapy (50.4 Gy) followed by 2-course of additional DNF therapy and 1-year S-1 maintenance therapy. 2) Salvage therapy for patients with recurrent lesion
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 thoracic esophageal cancer (UICC-TMN, 7th) (2) clinical stage IB-III (nonT4) (UICC-TMN, 7th) (3) no prior chemotherapy and radiotherapy (4) age 20-75 years (5) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (6) adequate baseline bone marrow function, adequate hepatic function, adequate renal function, adequate respiratory and cardiac function (7) no prior endoscopic or surgical resection for esophageal cancer (8) patients who are deemed to be tolerable for surgery, but refuse surgery as initial treatment modality (9) able to intake orally (10) a life expectancy of at least 3 months (11) written informed consent was obtained from all patients
Key exclusion criteria	(1) prior chemotherapy and radiotherapy (2) history of drug hypersensitivity (3) contraindication for docetaxel, nedaplatin , 5-FU, or G-CSF (4) active concomitant malignancy. (5) severe heart disease (6) severe diabetes mellitus, severe hypertension, active infection (7) interstitial pneumonia or pulmonary fibrosis (8) pregnant or lactating females (9) high fever (10) the investigator considers not suitable for the study
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	S1W16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	ohnuma@sapmed.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroyuki Ohnuma
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology
Zip code
Address	S1W16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Homepage URL
Email	ohnuma@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine, Department of Medical Oncology
Institute
Department

Funding Source
Organization	none
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	2016 Year 12 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	Terminated
Date of protocol fixation	2016 Year 08 Month 01 Day
Date of IRB	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028853