UMIN-CTR Clinical Trial

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

esophageal cancer

Classification by specialty

Gastroenterology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Isolated lymph node relapse rate

Key secondary outcomes

Complete response rate, progression free survival time, and frequency and degree of toxicity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Radiology, University of Tokyo Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

Organization

Address

Tel

Email

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

東京大学医学部付属病院（東京都）

Date of disclosure of the study information

2012

Year

02

Month

02

Day

URL releasing protocol

http://www.u-tokyo-rad.jp/2011/04/15180939.html

Publication of results

Published

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

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 related information

Registered date

2012

Year

02

Month

02

Day

Last modified on

2015

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008483