UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007408
Receipt number R000008729
Scientific Title Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer
Date of disclosure of the study information 2012/02/29
Last modified on 2012/02/29 16:05:35

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Basic information

Public title

Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer

Acronym

Phase II Trial of neoadjuvant chemotherapy with DCF for
esophageal cancer

Scientific Title

Phase II Trial of neoadjuvant chemotherapy with docetaxel, cisplatin and 5-FU for advanced esophageal cancer

Scientific Title:Acronym

Phase II Trial of neoadjuvant chemotherapy with DCF for
esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Surgery in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This phase I/II study is being conducted to determine the safety and the efficacy of neoadjuvant chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) for stage II/III esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Pathological response

Key secondary outcomes

Curative resection rate
Clinical response of chemotherapy
Postoperative complication
2y survival rate
3y survival rate


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

Chemotherapy using docetaxel+Cisplatin+5-FU
Surgical resection

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients who are going to undergo curative esophagectomy with 2F or 3F lymph node dissection
2)TNM stage II/III
3)ECOG performance status 0-1
4)20 years and older, 75 years and younger
5)Patients must have histologic confirmation of the diagnosis with tumor
6)Patients have not received prior chemotherapy nor chemoradiotherapy
7)Laboratory values as follows;
3000/mm3 < WBC < 12000/mm3
1500/mm3 < granulocyte count
8.0 gm/dl < hemoglobin
Platelet count > 100000/mm3
Aspartate transaminase < 150 IU/L
Alanine transaminase < 150 IU/L
Creatinine < 1.5 mg/dl
8)Able and willing to give valid written informed consent

Key exclusion criteria

Different histological type from squamous cell carcinoma or adenocarcinoma
Patient with allergic response to anticancer drugs (docetaxel, cisplatin, 5-FU)
Active or uncontrolled infection
Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
Clinically significant heart disease
Patients with a history of myocardial infarction within the previous three months
Patients with uncontrolled diabetes mellitus or hypertension
Patients with interstitial pneumonia or pulmonary fibrosis
Patients who receive hemodialysis
Presence of clinically apparent central nervous system metastases
Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
Decision of unsuitableness by principal investigator or physician-in-charge

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Iwahashi

Organization

Wakayama Medical Unversity

Division name

Second Department of Surgery

Zip code


Address

Kimiidera, Wakayama, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Makoto Iwahashi

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code


Address


TEL


Homepage URL


Email

makoto@wakayama-med.ac.jp


Sponsor or person

Institute

Second Department of Surgery, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Second Department of Surgery, Wakayama Medical University

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

2012 Year 02 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Enrolling by invitation

Date of protocol fixation

2011 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 29 Day

Last modified on

2012 Year 02 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name