UMIN-CTR Clinical Trial

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

advanced gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Weight control rate at 12 weeks

Key secondary outcomes

ORR and PFS of chemotherapy, OS, Safety, PG-SGA, FAACT

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

St.Marianna University School of Medicine

Institute

Department

Personal name

Organization

Eli Lilly Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2019

Year

09

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2019

Year

08

Month

31

Day

Last modified on

2021

Year

03

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043174