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
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
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
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
