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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000710
Receipt No. R000000843
Scientific Title Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Date of disclosure of the study information 2007/05/08
Last modified on 2015/09/11

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Basic information
Public title Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Acronym Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Scientific Title Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Scientific Title:Acronym Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)
Region
Japan

Condition
Condition esophageal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part: to evaluate maximum tolerating dose and dose-limiting toxicities to determine recommended dose of S-1 in combination with a fixed dose of cisplatin and radiotherapy in patients with clinical stage II/III esophageal carcinoma.

Phase II part: to evaluate complete response rate and validate the recommended dose based on frequency and degree of adverse events.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of dose limiting toxicity/Complete response rate
Key secondary outcomes Adverse event, Overall survival, Progression free 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 Maneuver
Interventions/Control_1 Concurrent chemoradiotherapy with S-1 and cisplatin
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) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage II or III without T4
4) Aged 20 to 70 years old
5) ECOG PS of 0 or1
6) no need for measurable lesion
7) no previous treatment of esophageal cancer
8) no previous chemotherapy or radiotherapy against any other malignancies
9) adequate water intake
10)no palsy of recurrent nerve
11) adequate organ functions
12) refused esophagectomy
13) written informed consent
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Pregnant or lactating women or women of childbearing potential
4) Psychosis
5) Patients requiring systemic steroids medication
6) HBs antigen positive
7) Uncontrollable diabetes millutus or requiring administration of insulin
8) Uncontrollable hypertension
9) History of myocardial infarction or unstable angina pectoris
10) Interstitial pneumonia, fibroid lung or severe emphysema
11) Active bacterial or fungous infection
Target sample size 81

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atushi Ohtsu, MD, PhD
Organization National Cancer Center Hospital East
Division name Research Center for Innovative Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Tahara, MD, PhD
Organization JCOG0604 Coordinating Office
Division name Outpatient division, National Cancer Center Hospital East
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 初回届出年月日:2007/4/23, 届出回数:1回

Institutions
Institutions 国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
慶應義塾大学病院(東京都)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2007 Year 05 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26250827
Number of participants that the trial has enrolled
Results See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
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 Main results already published
Date of protocol fixation
2007 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2014 Year 08 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
2007 Year 05 Month 08 Day
Last modified on
2015 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000843

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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