UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015550
Receipt No. R000018067
Official scientific title of the study Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma
Date of disclosure of the study information 2014/10/28
Last modified on 2016/11/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000018067

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form