UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003370
Receipt number R000004049
Scientific Title Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Date of disclosure of the study information 2010/03/25
Last modified on 2014/06/18 11:19:30

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Basic information

Public title

Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.

Acronym

T4/M1LYM DCF PI/II study

Scientific Title

Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.

Scientific Title:Acronym

T4/M1LYM DCF PI/II study

Region

Japan


Condition

Condition

esophageal neoplasm

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the safety and efficacy of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Complete response rate

Key secondary outcomes



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

Interventions/Control_1

docetaxel 70 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 750 mg/m2/day day1-5 civ
q3w , 3 cycle
5-fluorouracil 700mg/m2/day day1-5 civ
cisplatin 70mg/m2/day day1
RT 60Gy/30fr/6w
q2w ,2cycle

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) radiologist permits curative radiotherapy 60Gy
4) with T4 tumors and/or distant lymph node metastasis (M1LYM)
5) no lymph nodes more distant than
the celiac region in the abdomen/no distant organ metastases
6) no esophagobronchial fistulas/no esophagomediastinal fistulas,
7) Aged 20 to 70 years old
8) ECOG PS of 0 or 1
9) no previous treatment of esophageal cancer without endoscopic resection
10) no previous chemotherapy or radiotherapy against any other malignancies
11) adequate organ functions
12) 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) Pregnant or lactating women or women of childbearing potential
3) Psychosis
4) Patients requiring systemic steroids medication
5) HBs antigen positive
6) Uncontrollable diabetes millutus
7) History of myocardial infarction within three months
8) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
9) Active bacterial or fungous infection

Target sample size

30


Research contact person

Name of lead principal investigator

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

Organization

National Cancer Center Hospital East

Division name

Division of Digestive Endoscopy and GI Oncology

Zip code


Address

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

TEL

0471331111

Email

hsatake@kcho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironaga SATAKE,MD

Organization

National Cancer Center Hospital East

Division name

Division of Digestive Endoscopy and GI Oncology

Zip code


Address

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

TEL

078-302-4321

Homepage URL


Email

hsatake@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

none

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



Other administrative information

Date of disclosure of the study information

2010 Year 03 Month 25 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2009 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 01 Month 31 Day

Date trial data considered complete

2015 Year 02 Month 28 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 03 Month 24 Day

Last modified on

2014 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name