UMIN-CTR Clinical Trial

Public title

Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Acronym

Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Scientific Title

Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Scientific Title:Acronym

Phase I/II trial of chemoradiotherapy concurrent with S-1 and cisplatin in patients with clinical stage II/III esophageal carcinoma (JCOG0604)

Region

Japan

Condition

esophageal neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase I part: to evaluate maximum tolerating dose and dose-limiting toxicities to determine recommended dose of S-1 in combination with a fixed dose of cisplatin and radiotherapy in patients with clinical stage II/III esophageal carcinoma.

Phase II part: to evaluate complete response rate and validate the recommended dose based on frequency and degree of adverse events.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Incidence of dose limiting toxicity/Complete response rate

Key secondary outcomes

Adverse event, Overall survival, Progression free survival

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

Medicine

Maneuver

Interventions/Control_1

Concurrent chemoradiotherapy with S-1 and cisplatin

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

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage II or III without T4
4) Aged 20 to 70 years old
5) ECOG PS of 0 or1
6) no need for measurable lesion
7) no previous treatment of esophageal cancer
8) no previous chemotherapy or radiotherapy against any other malignancies
9) adequate water intake
10)no palsy of recurrent nerve
11) adequate organ functions
12) refused esophagectomy
13) written informed consent

Key exclusion criteria

1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Patients requiring the administration of phenytoin or warfarin potassium
3) Pregnant or lactating women or women of childbearing potential
4) Psychosis
5) Patients requiring systemic steroids medication
6) HBs antigen positive
7) Uncontrollable diabetes millutus or requiring administration of insulin
8) Uncontrollable hypertension
9) History of myocardial infarction or unstable angina pectoris
10) Interstitial pneumonia, fibroid lung or severe emphysema
11) Active bacterial or fungous infection

Target sample size

81

Name of lead principal investigator

1st name
Middle name
Last name	Atushi Ohtsu, MD, PhD

Organization

National Cancer Center Hospital East

Division name

Research Center for Innovative Oncology

Zip code

Address

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

TEL

Email

Name of contact person

1st name
Middle name
Last name	Makoto Tahara, MD, PhD

Organization

JCOG0604 Coordinating Office

Division name

Outpatient division, National Cancer Center Hospital East

Zip code

Address

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

TEL

04-7133-1111

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Center for Clinical Trials, Japan Medical Association

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

初回届出年月日：2007/4/23, 届出回数：1回

Institutions

国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院（東京都）
慶應義塾大学病院（東京都）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院（愛知県）

Date of disclosure of the study information

2007

Year

05

Month

08

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/26250827

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

2007

Year

02

Month

07

Day

Date of IRB

Anticipated trial start date

2007

Year

05

Month

01

Day

Last follow-up date

2014

Year

08

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

05

Month

08

Day

Last modified on

2015

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000843