UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017153
Receipt number R000019895
Scientific Title A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake
Date of disclosure of the study information 2015/04/16
Last modified on 2019/03/27 07:12:00

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Basic information

Public title

A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake

Acronym

A phase II study of neoadjuvant chemotherapy with DCS for esophageal cancer

Scientific Title

A phase II study of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 in advanced esophageal cancer patients with normal oral intake

Scientific Title:Acronym

A phase II study of neoadjuvant chemotherapy with DCS for esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This phase II study is being conducted to determine the efficacy of neoadjuvant chemotherapy using docetaxel, cisplatin and S-1 (DCS) for stage IB/II/III esophageal cancer with normal oral intake

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Pathologocal response

Key secondary outcomes

Curative resection rate
Clinical response of chemotherapy
Toxicities 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+S-1 followed by surgicalresection

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 must have historogic confirmation of squamous cell carcinoma or adenocarcinoma or basaloid carcinoma by endoscopic biopsy
(2) TMN stage IB/II/III
(3) 20 years and older, 75 years and younger
(4) ECOG performance status 0-1
(5) Patients have not received prior chemotherapy or radiotherapy
(6) Patients who are going to under curative esophagectomy (R0)
(7) Patients with normal oral intake
(8) Lavoratory values as fellows;
4000 < WBC < 12000/mm3
granulocyte count > 2000/mm3
Hemoglobin > 8.0 g/dL
Platelet count > 100,000/mm3
AST, ALT < 100 IU/L
T-bil < 1.5 mg/dL
Cr < 1.2 mg/dL
Ccr > 60 mL/min/body

Key exclusion criteria

(1)Patients with concurrent other primary cancer requiring treatment
(2)Pregnancy, possible pregnancy after delivery or breast feeding
(3)Patients requiring systemic administration of steroid
(4)Positive HBs antigen
(5)Patients requiring flucytosine or phenytoin or warfarine administration
(6)Patients for allergy of iodine
(7)Patient with allergic response to anticancer drugs (docetaxel, cisplatin, S-1)
(8)Severe peripheral nerve disorder
(9)Patients with interstitial pneumonia or pulmonary fibrosis
(10)Active infection
(11)Patients with a history of myocardial infarction or unstable angina pectoris within the previous six months
(12)Patients with uncontrolled hypertension or diabetes melitus

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mikihito Nakamori

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Email

chamcham@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mikihito Nakamori

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Homepage URL


Email

chamcham@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

2015 Year 04 Month 16 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

Completed

Date of protocol fixation

2014 Year 06 Month 20 Day

Date of IRB

2014 Year 06 Month 10 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 16 Day

Last modified on

2019 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019895


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name