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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007209
Receipt No. R000008483
Scientific Title Prospective study about radiation field setting based on 18FDG-PET in definitive chemoradiation for the inoperable local advanced esophageal cancer.
Date of disclosure of the study information 2012/02/02
Last modified on 2015/08/02

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Basic information
Public title Prospective study about radiation field setting based on 18FDG-PET in definitive chemoradiation for the inoperable local advanced esophageal cancer.
Acronym Radiation field setting in chemoradiation for esophageal cancer.
Scientific Title Prospective study about radiation field setting based on 18FDG-PET in definitive chemoradiation for the inoperable local advanced esophageal cancer.
Scientific Title:Acronym Radiation field setting in chemoradiation for esophageal cancer.
Region
Japan

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

Objectives
Narrative objectives1 To perform a prospective study about chemoradiation using selective lymph node irradiation based on 18FDG-PET for local advanced esophageal cancer.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Isolated lymph node relapse rate
Key secondary outcomes Complete response rate, progression free survival time, and frequency and degree of toxicity

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
Maneuver
Interventions/Control_1 Duration of chemoradiation was 6 weeks.

Radiation consists of 50Gy - 50.4 Gy delivered in 1.8 Gy - 2 Gy per fraction over 5 W - 5.6 weeks.

Clinical target volume was defined as the primary tumor and FDF-PET positive lymph node.

Two cycles of 5-fluorouracil consists of 800 mg/m2/day, days 1-4 & days 29-32, continuous.

Nedaplatin consists of 80 mg/m2, day 1 & day 29, bolus.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. histopathologically proven invasive esophageal cancer

2. clinical stage I without indicationf of ESD/EMR or clinical stages II - IV

3. PS: 0-2

4. written informed consent

5. WBC: 4000-12000/mm3, Neu > 2000/mm3, Plt > 100,000/mm3, Hb > 9.0g/dL, Tbil < 1.5mg/dL, GOT/GPT < 76/72U/L, Cre < 1.2mg/dL, PaO2 > 70mmHg
Key exclusion criteria 1. having serious complications

2. having synchronism overlap cancer

3. having metastasis to other organs

4. with a history of radiation for the same lesion

5. with a history of chemothrapy

6. having administration contraindication of nedaplatin/5-FU

7. having drug hypersensitivity

8. A woman with the possibility (intention) of the pregnancy, a pregnant woman

9. charging doctor regards as inadequacy because of medical, psychologically, or other factors
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hideomi Yamashita
Organization University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8667
Email yamachan07291973@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hideomi Yamashita
Organization University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8667
Homepage URL http://www.cc.h.u-tokyo.ac.jp/mulins/gcp/jisshichuujishurinshou.pdf
Email yamachan07291973@yahoo.co.jp

Sponsor
Institute Department of Radiology, University of Tokyo Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 P2010052-11Z
Org. issuing International ID_1 University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 02 Day

Related information
URL releasing protocol http://www.u-tokyo-rad.jp/2011/04/15180939.html
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25466372
Number of participants that the trial has enrolled
Results
From September 2009 to July 2012, of the 63 patients enrolled, 58 were evaluable for response. The primary end point of isolated out-of-field loco-regional nodal recurrence was seen in only two patients. The expectant rate was assumed to be less than 5%. The threshold value was set as 10% to calculate the number of registrations. Progression-free and overall survival rates at 36months were 47.7% and 51.1%, respectively. The median progression-free survival was 34.6months, and overall survival was 38.4months. Salvage surgery was tried for 11 patients (17.5%) due to residual or recurrent disease.
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
2011 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2012 Year 02 Month 02 Day
Last modified on
2015 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008483

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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