UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013999 |
|---|---|
| Receipt number | 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 18:34:56 |
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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
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
rkawai@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016310
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