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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013999
Receipt No. R000016310
Scientific Title A study of the safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant chemotherapy (NAC) during the perioperative period.
Date of disclosure of the study information 2014/05/19
Last modified on 2017/05/24

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Basic information
Public title A study of the safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant chemotherapy (NAC) during the perioperative period.
Acronym Safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF as neoadjuvant chemotherapy (NAC).
Scientific Title A study of the safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant chemotherapy (NAC) during the perioperative period.
Scientific Title:Acronym Safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF as neoadjuvant chemotherapy (NAC).
Region
Japan

Condition
Condition thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy to use synbiotic treatment in patients with thoracic esophageal cancer who received DCF as neoadjuvant chemotherapy (NAC).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Probability of more than grade3 oral mucosal damage during NAC.
Key secondary outcomes (1)Febrile neutropenia,(2)Adverse event occurrence rate,(3)Postoperative infectious complication,(4)Perioperative complication,(5)Duration of SIRS,(6)Duration of ICU admission,(7)Postoperative length of stay,(8)Clinical response rate,(9)Pathological complete response

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 During NAC period and the perioperative period, take in Bio-Three 3 gram and GFO 3 packs to a meal three times a day.
Synbiotic treatment during NAC:oral intake,Bio-Three ( Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus), GFO( glutamine, fiber, oligosaccharide)
Postoperative synbiotic treatment:through the enteral feeding tube, Bio-Three( Streptococcus faecalis, Clostridium butyricum, Bacillus mesentericus), GFO( glutamine, fiber, oligosaccharide)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Thoracic esophageal cancer who received DCF therapy for neoadjuvant chemotherapy.
2.R0 esophagectomy is judged as possible by thoracotomy (or thoracoscopic surgery) and laparotomy (or laparoscopic surgery).
3.Bio-Three and GFO intake is possible.
4.ECOG<2.
5.Adequate organ functions.
6.Written informed consent.
Key exclusion criteria 1.Simultaneous or metachonous double cancers.
2.Uncontrolled active infectious disease requiring systemic treatment.
3.Positive HBs antigen, HCV antibody or HIV antibody.
4.Pregnant or women of childbearing potential
5.Patients requiring systemic administration of steroids.
6.Uncontrolled psychiatric disease.
7.History of myocardial infarction within 6 months or unstable angina.
8.Severe emphysema or pulmonary fibrosis.
9.Diabetes mellitus with HbA1c of 8.0% or higher.
10.Physician judgment disqualified.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Abe
Organization Aichi Cancer Center Central Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Email tabe@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Kawai
Organization Aichi Cancer Center Central Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL 052-762-6111
Homepage URL
Email rkawai@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 愛知県がんセンター中央病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 19 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 04 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 21 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
2014 Year 05 Month 19 Day
Last modified on
2017 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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