UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017153
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Second Department of Surgery, Wakayama Medical University
Institute
Department

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
URL(English) https://upload.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


Contact us.