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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014613
Receipt No. 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

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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
Email 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
Email yakutsu@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017005

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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