UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014613 |
|---|---|
| Receipt number | R000017005 |
| Scientific Title | The effect of elemental diet with fluorouracil, cisplatin and leucovorin(LV+FP) in esophagus cancer patients |
| Date of disclosure of the study information | 2014/07/22 |
| Last modified on | 2016/01/22 13:17:18 |
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Basic information
Public title
The effect of elemental diet with fluorouracil, cisplatin and leucovorin(LV+FP) in esophagus cancer patients
Acronym
The effect of elemental diet for FPL chemotherapy
Scientific Title
The effect of elemental diet with fluorouracil, cisplatin and leucovorin(LV+FP) in esophagus cancer patients
Scientific Title:Acronym
The effect of elemental diet for FPL chemotherapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of elemental diet with fluorouracil, cisplatin and leucovorin in esophagus cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of oral mucositis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elental
Interventions/Control_2
Control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The primary tumor is located within the neck, the chest or the abdominal esophagus.
2. Pathologically proven squamous, adenosquamous or adenocarcinoma.
3. Stage 0-IV
4. 20 years old or more.
5. ECOG PS2 or less.
6. Without brain metastases.
7. Without pleural effusion, ascites.
8. Elemental diet can be administered orally or by tube feeding.
9. Naive for chemotherapy or 1 or more months have been passed after prior chemotherapy.
10. Patients underwent oral care with explamation of oral hygene.
11. Informed consent is obtained.
Key exclusion criteria
1. Diabetes Mellitus which requires continuous insulin administration.
2. Active double cancers.
3. Hypersensitivity for CDDP, leucovorin and 5-FU.
4. Contraindication of elental.
5. Active infections.
6. Continuous administration of steroids.
7. Neural paralysis (CTCAE v4.0 Grade1 or more).
8. Edema(CTCAEv4.0 Grade1 or more).
9. Plumonary fibrosis, pneumonitis.
10. psycholotical issues.
11. Patients enrolled in other clinical trials in which the endpoints are same.
12. Pregnant patients.
13. Inappropriate patients that doctors judged.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Chiba University
Division name
Graduate School of Medicine, Frontier Surgery
Zip code
Address
1-8-1, Inohana, Chuoku, Chiba
TEL
043-226-2110
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Akutsu |
Organization
Chiba University
Division name
Department of Frontier Surgery
Zip code
Address
1-8-1, Inohana, Chuoku, Chiba
TEL
043-226-2110
Homepage URL
yakutsu@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2014 | Year | 07 | Month | 22 | 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
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 29 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2016 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017005
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
