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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007814
Receipt No. R000009206
Scientific Title Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Date of disclosure of the study information 2012/05/02
Last modified on 2017/11/06

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Basic information
Public title Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Acronym HGCSG1202
Scientific Title Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Scientific Title:Acronym HGCSG1202
Region
Japan

Condition
Condition metastatic or advanced gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of nutritional intervention by elemental diet on improvement in medical treatment results, incidence of digestive organ toxicity, etc. compared with no nutritional intervention in patients with chemotherapy for metastatic or advanced gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time to Treatment Failure
Key secondary outcomes 1) Incidence of adverse events (particularly stomatitis incidences, diarrhoea incidence, etc.), 2) Body weight change, 3) Serum albumin change, 4) Relative dose intensity, 5) Safety, 6) Compliance of elemental diet, 7) The number of first-line cycles, 8) response of the tumor, 9) Progression free survival, 10) Overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Two packs (600kcal) intake of elemental diet (Elental) is orally performed a day. An administration period makes it every day from the start dates (the first course Day 1) till the end of the first-line treatment. If it is difficult to intake elemental diet because of taking enough food, the calorie per day is deducted 600kcal, as dosing elemental diet per day, from diet meal in advance. Elemental diet continues for two packs in principle. In addition, it is arbitrary about the elemental diet administration after second-line treatment.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with histologically proven unresectable progression or relapse gastric cancer.
(2) Patients with the following regimen as first-line treatment,
S-1 + cisplatin, capecitabine + cisplatin, capecitabine + cisplatin + trastuzumab
(3) Patients in whom oral intake of staple food is possible during a study periods
(4) Aged 20 or older
(5) ECOG performance status 0-2
(6) Patients by whom the survival for three months or more is anticipated from the registration.
(7) Written informed consent obtained.
<<laboratory evidence>>
1) Hemoglobin >= 8.0g/dL
2) Neutrophil counts >= 1,000/mm3 or white blood cell counts >= 2,000/mm3
3) Platelet counts >= 75,000 /mm3
4) T-Bil <= 3mg /dL
5) AST or ALT < 150 IU/L
6) Creatinine clearance >= 50 mL/min (it computes based on a Cockcroft-Gault equation).
Key exclusion criteria (1) Patients who recieved nutritional therapy for one week or more within the past two months
(2) Patient who took L-glutamine quantity content drugs (marzulene, GFO, etc.) for less than two weeks of past.
(3) Patients who are associated with uncontrollable abnormal glucose tolerance
(4) Patients who are associated with critical complications
(5) Pregnancy and lactation, and/or without intention of birth control.
(6) Patients with mental disorders
(7) Patients applicable to contraindications of each use drugs.
(8) Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Department of Cancer Chemotherapy
Zip code
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nao Horie
Organization Hokkaido University Hospital
Division name Department of Clinical Trial Management
Zip code
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL 011-706-7413
Homepage URL
Email nhorie@med.hokudai.ac.jp

Sponsor
Institute NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization AJINOMOTO PHARMACEUTICALS CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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 北海道大学病院、他、HGCSG参加施設ならびに研究協力施設(約30施設)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 02 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 23 Day
Last modified on
2017 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009206

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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