UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of chemoradiotherapy (50.4Gy, modified 5-FU+CDDP) for clinical Stage II/III esophageal carcinoma
Acronym	Stage II/III esophageal carcinoma: CRT based on the RTOG regimen Phase II
Scientific Title	Phase II trial of chemoradiotherapy (50.4Gy, modified 5-FU+CDDP) for clinical Stage II/III esophageal carcinoma
Scientific Title:Acronym	Stage II/III esophageal carcinoma: CRT based on the RTOG regimen Phase II
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of 50.4Gy, modified 5-FU+CDDP chemoradiotherapy for clinical stage II/III (non T4) esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	1-year survival rate
Key secondary outcomes	3-year survival rate, progression free survival, CR rate, toxicity rate, late toxicity rate

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	50.4Gy, modified 5-FU+CDDP chemoradiotherapy
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Thoracic esophageal cancer siagnosed as squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma. 2. Clinical UICC-stageII/III (non-T4) 3. No prior therpy for esophageal cancer and no chemotherapy for other disease 4. PS(ECOG): 0, 1 5. Not to select surgery 6. Written informed consent 7. Normal bone marrow, liver and renal function
Key exclusion criteria	1. Fistula 2. Sever complications 3. Active infection 4. Past history of radiotherapy of chest 5. Intersitial pneumonia or fibrosis 6. Active double cancer 7. Pregnancy 8. Mental illness
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken Kato
Organization	National Cancer Center Hospital, Tokyo
Division name	Gastrointestinal Oncology
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email

Public contact
Name of contact person	1st name Middle name Last name Takako Eguchi Nakajima
Organization	National Cancer Center Hospital, Tokyo
Division name	Outpatient Oncology
Zip code
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	taeguchi@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Tokyo
Institute
Department

Funding Source
Organization	National Cancer Center Hospital, Tokyo
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shizuoka Cancer Center, Kyushu University, Jichi Medical University, Kitasato University, Aichi Cancer Center, Osaka City Medical Center, Tochigi Cancer Center, Hokkaido University
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	2007 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2006 Year 05 Month 25 Day
Date of IRB	2013 Year 10 Month 10 Day
Anticipated trial start date	2006 Year 05 Month 01 Day
Last follow-up date	2017 Year 03 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	2007 Year 10 Month 18 Day
Last modified on	2022 Year 08 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001030