UMIN-CTR Clinical Trial

Public title

Feasibility study of agjuvant chemotherapy with docetaxel, cisplatin and fluorouracil for esophageal cancer

Acronym

Feasibility study of agjuvant chemotherapy for esophageal cancer

Scientific Title

Feasibility study of agjuvant chemotherapy with docetaxel, cisplatin and fluorouracil for esophageal cancer

Scientific Title:Acronym

Feasibility study of agjuvant chemotherapy for esophageal cancer

Region

Japan

Condition

esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is elucidate the anticancer efficacy and feasibility of docetaxel, cisplatin and fluorouracil for advanced esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Completion rate of 2 cycles

Key secondary outcomes

Adverse event
Adverse eventProgression free survival
Overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

docetaxel(70mg/m2/day) day1
cisplatin(70mg/m2/day1) day1
5-fluorouracil(700mg/m2/day) day1-5
q4w, 2 cycle

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1,5)Patients with esophageal SCC who underwent currative (R0) resection without preoperative treatment and had pathological LN metastases

2)TNM stage 2 and 3
3)Age of 20 to 74 years with either gender and ECOG Performance Status of 0 to 2
4)No past history of chemotherapy, irradiation and operation for esophageal cancer
6)Laboratory values as follows
4000/mm3 < WBC < 12000mm3
2000/mm3 < Nuetrophil
100000/mm3 < Platelet count
9.0g/dL Hemoglobin
AST,ALT < 2.0 times of normal upper
limits
Serum creatinine < 1.2mg/dL
60ml/min < Cleatinine clearance

7)Written informed consent

Key exclusion criteria

1) Past history of drug allergy
2)Past history of drug allergy of
docetaxel, cisplati and fluorouracil
3)Patient with clinically obvious
infecton
4)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
5)Disease that is serious or requires hospitalization, or history of such disease within past year
6)Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
7)Massive pleural effusion, ascites and pericardial effusion
8)Gastrointestinal hemorrhage
9)Chronic diarrhea (watery stool or 4 times or more/day)
10)Active hepatitis type HBs positive
11)More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
12)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Email

norinori@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Hirahara, M.D., Ph.D.

Organization

Shimane University Hospital

Division name

Digestive and General Surgery

Zip code

Address

89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan

TEL

0853-20-2232

Homepage URL

Email

norinori@med.shimane-u.ac.jp

Institute

Shimane University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

none

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

Institutions

島根大学附属病院

Date of disclosure of the study information

2012

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

19

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

10

Month

19

Day

Last modified on

2014

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010727