UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study to evaluate the efficacy of elemental diet in metastatic or advanced gastric cancer patients treated with chemotherapy.
Title of the study (Brief title)	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	Yoshito Komatsu
Organization	Hokkaido University Hospital
Division name	Department of Cancer Chemotherapy
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	Nao Horie
Organization	Hokkaido University Hospital
Division name	Department of Clinical Trial Management
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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