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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025412
Receipt No. R000029254
Scientific Title Study on elemental diet for oral mucositis of DCF in patients with esophageal cancer -Randomized Phase III study: EPOC2 study-
Date of disclosure of the study information 2017/01/05
Last modified on 2019/09/02

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Basic information
Public title Study on elemental diet for oral mucositis of DCF in patients with esophageal cancer -Randomized Phase III study: EPOC2 study-
Acronym EPOC2 study -elementary diet for oral mucositis in patients with esophageal cancer receiving chemotherapy-
Scientific Title Study on elemental diet for oral mucositis of DCF in patients with esophageal cancer -Randomized Phase III study: EPOC2 study-
Scientific Title:Acronym EPOC2 study -elementary diet for oral mucositis in patients with esophageal cancer receiving chemotherapy-
Region
Japan

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

Objectives
Narrative objectives1 Effect of elemental diet against oral mucositis on DCF chemotherapy for esophageal cancer patients
Basic objectives2 Others
Basic objectives -Others Oral mucositis of more than Grade 2
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Oral mucositis of more than Grade 2
Key secondary outcomes ・Body weight, CRP, Alb, Prealbumin,
lymphocytic change between two groups
・incidence of oral mucositis on cases of neoadjuvant chemotherapy and inoperable/ recurrent cancer
・adverse event except mucositis
・Kaplan-Maier curve for inicial incidence of oral mucositis on every grade
・grade of examination findings and function/ symptom of oral mucositis between two groups and its timing
・compliance of elemental diet and DCF therapy
・oral mucositis of more than grade 2 and completion rate of DCF therapy between two groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A (DCF + elemental diet)
Docetaxel, cisplatin, 5-fluorouracil (2 courses)
Docetaxel(DOC) 35mg/m2 day1, day15
Cisplatin(CDDP) 40mg/m2 day1, day15
Fluorouracil (5-FU) 400mg/m2 day1-5, day15-19
(4 weeks)

Administration of elemental diet: 2 packets per day (9 weeks)
Interventions/Control_2 Group B (DCF)
Docetaxel, cisplatin, 5-fluorouracil (2 courses)
Docetaxel(DOC) 35mg/m2 day1, day15
Cisplatin(CDDP) 40mg/m2 day1, day15
Fluorouracil (5-FU) 400mg/m2 day1-5, day15-19
(4 weeks)
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) Histologically revealed squamous cell carcinoma and adenosquamous cell carcinoma and adenocarcinoma.*
Synchronous multiple esophageal carcinoma cases that can be treated at one time and metachronous multiple carcinoma cases can be registered. Even in the presence of simultaneous or metachronous duplicated cancers, registration can be posible if this chemotherapy regimen (Biweekly-DCF) is clinically given with priority for the treatment of esophageal cancer.
*In case of esophageal adenocarcinoma, Siewert type I is only allowed.
2) The following cases where DCF therapy can be started within 3 weeks after registration. (UICC TNM Classification 7th Edition)
i) Neoadjyuvant chemotherapy cases for Stage II,III.
ii) Inoperable, recurrent cases
3) 20<= years old
4) PS(ECOG)0 or 1
5) BSA(DuBois)<=2.2m2
6) ・4,000 /mm3<= WBC<=12,000/mm3
・Neutro>=2,000 /mm3
・Plt>=100,000 /mm3
・Hb>=8.0 g/dL
・AST<=100 IU/L
・ALT<=100 IU/L
・T.Bil<=1.2 mg/dL
・Cre<=1.2 mg/dL
・ccr>=50 mL/min
*Ccr estimated by Cockcroft-Gault formula as 50 mL/min or more, or 40 mL / min or more and serum creatinine value is 1.2 mg / dL or less were able to be registerd.
7) Dysphagia score<=2
8) required to sign an informed consent form approved by the Ethical Committee
Key exclusion criteria 1) Diabetes mellitus using insulin.
3) Women who are pregnant or breast feeding
4) A woman who is likely to become pregnant, a man with productive ability.
5) Cases in which the endpoint participates in another clinical trial with overlapping.
6) Cases with a history of hypersensitivity to DOC, CDDP, 5-FU, and polysorbate 80 containing formulations.
7) Cases in which administration of Elental is contraindicated.
8) Cases under active infection
9) Steroidal users.
10) Neurological deficit. >=G1
11) Edema >=G2
12) Intestinal pneumonia
13) Cases in which psychosis or psychiatric symptoms are merged and it is deemed difficult to participate in the study.
14) Judged by physicians as inappropriate for this study.
15) Cases with chronic hepatitis / liver cirrhosis status.
16) Cases with symptomatic bone metastasis / brain metastasis at registration.
17) Cases with massive pleural effusion (occupying more than 1/2 of either of the right or left chest cavity) or massive ascites (continuing from the pelvic area to the upper abdomen) at registration.
18) At the time of enrollment (CTCAE v3.0), cases of oral mucositis of Grade 1 or higher.
19) Cases of severe damping symptoms
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa(1) Kazuhiro Yoshida(2)
Organization Keio university school of medicine(1)
Gifu University(2)
Division name General and gastroenterological surgery(1) Surgical oncology(2)
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo(1) 1-1 Yanagido, Gifu city, Gifu Pref.(2)
TEL 03-3353-1211(1)058-230-6000(2)
Email jfmc49@jfmc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Tanaka
Organization Gifu university
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido, Gifu city, Gifu Pref.
TEL 058-230-6000
Homepage URL http://www.jfmc.or.jp/
Email jfmc49@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization EA Pharma.,Co.Ltd
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 01 Month 05 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
2016 Year 11 Month 07 Day
Anticipated trial start date
2017 Year 01 Month 05 Day
Last follow-up date
2019 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029254

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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