UMIN-CTR Clinical Trial

Basic information
Public title	An observational cohort study on the nutrition status of patients with advanced gastric cancer who receive combination chemotherapy with ramucirumab and a taxane
Acronym	Balast study
Scientific Title	An observational cohort study on the nutrition status of patients with advanced gastric cancer who receive combination chemotherapy with ramucirumab and a taxane
Scientific Title:Acronym	Balast study
Region	Japan

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

Objectives
Narrative objectives1	To estimate the weight control rate at 12 weeks in patients with AGC who are being treated with combination chemotherapy consisting of ramucirumab and a taxane.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Weight control rate at 12 weeks
Key secondary outcomes	ORR and PFS of chemotherapy, OS, Safety, PG-SGA, FAACT

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients fulfilling the following criteria will be enrolled: Patients who: - Are >20 years old, - Have histologically confirmed advanced gastric adenocarcinoma, - Have advanced gastric cancer with evaluable lesions, - Are scheduled to receive combination chemotherapy with ramucirumab and a taxane, - Can use electric devices (PCs, tablets, or mobile phones/cell phones) at home, and - Have provided written informed consent.
Key exclusion criteria	Patients fulfilling any of the following criteria will not be enrolled in any component of the study. Patients who: - Are unable to receive nutrition orally, - Have documented and/or symptomatic brain or leptomeningeal metastases, - Have experienced any episodes of Grade 3-4 gastrointestinal bleeding within 3 months prior to enrollment, - Have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to enrollment, - Have an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator, - Have an ongoing or active psychiatric illness or a social situation that would limit compliance with the study requirements, - Have uncontrolled or poorly controlled hypertension despite standard medical management, - Have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment, - Have undergone major surgery within 28 days prior to randomization or the placement of a subcutaneous venous access device within 7 days prior to enrollment, - Are receiving chronic antiplatelet therapy including the use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole, clopidogrel, or similar agents with the exception of once-daily aspirin use (maximum dose, 325 mg/day), and - Are scheduled to receive elective or planned major surgery during the course of the study.
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Takuro Middle name Last name Mizukami
Organization	St.Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	2168511
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
TEL	0449778111
Email	tnakajima@marianna-u.ac.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Mizukami
Organization	St.Marianna University School of Medicine
Division name	Department of Clinical Oncolgy
Zip code	2168511
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
TEL	0449778111
Homepage URL
Email	t3mizukami@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Eli Lilly Japan K.K.
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	St.Marianna University School of Medicine
Address	Sugao 2-16-1, Miyamae, Kawasaki, Kanagawa
Tel	044-977-8111
Email	t3mizukami@marianna-u.ac.jp

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	聖マリアンナ医科大学病院（神奈川県）、川崎市立多摩病院（神奈川県）、愛知県がんセンター中央病院（愛知県）、埼玉県立がんセンター（埼玉県）、大阪労災病院（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 03 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	2019 Year 07 Month 17 Day
Date of IRB	2019 Year 10 Month 08 Day
Anticipated trial start date	2019 Year 10 Month 08 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The study will be conducted as a Japanese, prospective, multicenter observational study in patients diagnosed as having AGC who will begin receiving combination chemotherapy consisting of ramucirumab and a taxane. Patients are to be enrolled into the study no earlier than the decision to initiate treatment with ramucirumab and a taxane and no later than the first dose of the treatment. It is mandatory that the treating physician's decision to start treatment with ramucirumab and a taxane is made independently and prior to the decision to invite the patient to participate in the study. As part of the routine care, patients who are malnourished and at risk of malnutrition will receive nutrition support from dietitians for a maximum of 3 months. Physicians will be asked to enroll eligible patients consecutively until the maximum inclusion threshold is reached or until the end of a 1.5-year enrollment inclusion period (whichever occurs first). Patients will be followed from the index date (i.e., treatment initiation) until death, withdrawal of consent, loss of follow up/record, or the end of the study, whichever comes first. During the follow-up period, assessment schedules will be adopted according to routine local clinical practice.

Management information
Registered date	2019 Year 08 Month 31 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043174