UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015550
Receipt number R000018067
Scientific Title 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 08:43:22

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Basic information

Public title

Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma

Acronym

EC-CPT-P1

Scientific Title

Phase I trial of definitive chemoprotontherapy in patients with clinical stage IB/II/III esophageal carcinoma

Scientific Title:Acronym

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

1st name
Middle name
Last name Tetsuo Akimoto

Organization

National Cancer Center Hospital East

Division name

Radation oncology Division

Zip code


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

1st name
Middle name
Last name Masakatsu Onozawa

Organization

National Cancer Center Hospital East

Division name

Radation oncology Division

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

maonozaw@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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)



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

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


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

Open public recruiting

Date of protocol fixation

2014 Year 09 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018067


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name