UMIN-CTR Clinical Trial

Public title

Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer

Acronym

Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer

Scientific Title

Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer

Scientific Title:Acronym

Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer

Region

Japan

Condition

esophageal cancer

Classification by specialty

Hematology and clinical oncology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the efficacy, we conduct phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for esophageal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

objective response rate

Key secondary outcomes

duration of response, time to progression, time to treatment failure, overall survival, feasibility

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/cisplatin/5-fluorouracil (docetaxel 60 mg/sm day1, cisplatin 70 mg/sm day1, 5-fluorouracil 600 mg/sm day1-5) given every 4 weeks

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Pathologically proven advanced esophageal cancer (Stage II to IV).
(2) Written informed consent is obtained from patient.
(3) Major organs are in normal conditions.
Hemoglobin => 8.0g/dL
White blood cell count 3,000 to 12,000/mm3
Neutrophil count => 1,500/mm3
Platelet count => 80,000/mm3
Serum bilirubin <= 2.0 times upper limit of normal
AST, ALT <= 3.0 times upper limit of normal
Serum creatinine <= 1.4 mg/dL

Key exclusion criteria

(1) Known hypersensitivity to taxanes, platinum, fluoropyrimidines. Known dihydropyrimidine-dehydrogenase (DPD) deficit.
(2) Pre-existing motor or sensory neurotoxicity of a severity => Grade2
(3) Active infectious diseases.
(4) Symptomatic bleeding tendency, coagulation disorder, or coagulation factor deficiency.
(5) Uncontrollable hypertension, uncontrollable diabetes, unstable angina, or heart failure.
(6) Pre-existing renal insufficiency or proteinuria => 2+.
(7) Clinical or radiographic signs of interstitial pneumonia or pulmonary fibrosis.
(8) Active gastrointestinal bleeding, bowel obstruction.
(9) Patients who are judged inappropriate for the entry into this study by the investigator.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiro Arakawa

Organization

Jikei university school of medicine

Division name

Department of oncology and hematology

Zip code

Address

3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan

TEL

03-3433-1111

Email

yarakawa@jikei.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuhiro Arakawa

Organization

Jikei university school of medicine

Division name

Department of oncology and hematology

Zip code

Address

3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan

TEL

03-3433-1111

Homepage URL

Email

esophagus@jikei.ac.jp

Institute

Jikei university school of medicine, department of oncology and hematology, department of gastroenterological surgery

Institute

Department

Personal name

Organization

Jikei university school of medicine, department of oncology and hematology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Institutions

Date of disclosure of the study information

2012

Year

07

Month

11

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

No longer recruiting

Date of protocol fixation

2012

Year

06

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

07

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

07

Month

11

Day

Last modified on

2016

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009877