UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma
Title of the study (Brief title)	EC-CPT-P1
Region	Japan

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

Objectives
Narrative objectives1	To determine the recommended dose of proton beam therapy for esophageal cancer concurrently with chemotherapy of CDDP and 5-FU
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Proportion of dose limiting toxicity
Key secondary outcomes	Adverse event, Complete response 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 Device,equipment
Interventions/Control_1	Proton beam therapy concurrently with chemotherapy
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 squamous cell carcinoma or adenosquamous cell carcinoma 2) Primary lesion are located within the thoracic esophagus 3) Clinical stage IB or II or III (non-T4) 4) Aged 20 to 75 years old 5) ECOG PS of 0 or1 6) adequate organ functions 7) no previous treatment of esophageal cancer except EMR or ESD 8) no previous chemotherapy or radiotherapy against any other malignancies 9) written informed consent
Key exclusion criteria	1. Active double cancer 2. Active infection 3. Body temperature is under 38 centigrade 4. Possible pregnancy 5. Severe psychological disease 6. Systemic steroid user 7. Positive HBs antigen 8. Uncontrolled diabetes 9. Uncontrolled hypertension 10. Unstable angina, cardiac infarction within 6 months before enrollment 11. Interstitial pneumonitis, pulmonary fibrosis, severe emphysema, heart failure 12. Cerebrovascular disease within 6 months before enrollment 13. History of iodine allergy
Target sample size	12

Research contact person
Name of lead principal investigator	Tetsuo Akimoto
Organization	National Cancer Center Hospital East
Division name	Radation oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	takimoto@east.ncc.go.jp

Public contact
Name of contact person	Masakatsu Onozawa
Organization	National Cancer Center Hospital East
Division name	Radation oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	maonozaw@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立研究開発法人　国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 18 Day
Anticipated trial start date	2014 Year 10 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 28 Day
Last modified on	2016 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018067