UMIN-CTR Clinical Trial

Public title

Impact of frailty on prognosis in elderly patients with gastrointestinal malignancies

Acronym

Impact of frailty on prognosis in elderly cancer patients

Scientific Title

Impact of frailty on prognosis in elderly patients with gastrointestinal malignancies

Scientific Title:Acronym

Impact of frailty on prognosis in elderly cancer patients

Region

Japan

Condition

Gastrointestinal Cancer (Esophagus, Stomach, Colon, Rectum)

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the impact of frailty on the prognosis in elderly patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

3-year survival rate, 3-year disease free survival rate

Key secondary outcomes

i) The association between clinical frailty scale and other evaluation scale (G8, EQ-5D-5L)
ii) The association between clinical frailty scale and nutrition status/sarcopenia
iii) Short-term outcomes
iv) Postoperative change regarding nutritional status and sarcopenia
v) Evaluation of nutritional guidance and support by registered dietitian
vi) Impact of frailty on dose intensity of adjuvant chemotherapy
vii) Comparison to historical data regarding short term outcomes and 3-year survival rate

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

i) 75 years old or older
ii) Primary gastroenterological cancer that is histologically proven malignancy and that expected to be R0 resection.
iii) Written informed consent

Key exclusion criteria

i) Cancer treatment has already administered at other hospital
ii) Synchronous cancer
iii) Systemic active infectious disease
iv) When the examining physician judged that the patient is not adequate for this study.

Target sample size

245

Name of lead principal investigator

1st name	Koichi
Middle name
Last name	Suda

Organization

Fujita Health University

Division name

Department of Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan

TEL

+81-562-93-9254

Email

iuyama@fujita-hu.ac.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Tanaka

Organization

Fujita Health University

Division name

Department of Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan

TEL

+81-562-93-9254

Homepage URL

Email

tsuyoshi.tanaka@fujita-hu.ac.jp

Institute

Department of Surgery, Fujita Health University

Institute

Department

Personal name

Organization

Department of Surgery, Fujita Health University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Fujita Health University Institutional Review Board

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan

Tel

+81-562-93-2865

Email

f-irb@fujita-hu.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

藤田医科大学病院（愛知県）

Date of disclosure of the study information

2020

Year

12

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

223

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

2020

Year

10

Month

19

Day

Date of IRB

2020

Year

10

Month

19

Day

Anticipated trial start date

2020

Year

12

Month

01

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

From Dec 2020 to May 2023, 245 elderly patients will be registered who met the following criteria: 1) 75years or older, 2) Primary gastroenterological cancer that is histologically proven malignancy and that expected to be R0 resection, 3) obtained written informed consent from patients. These patients will be followed up to at least 3 years.
We will prospectively collect the data of patients regarding frailty and sarcopenia as well as other clinical laboratory at the following time: first visit to our hospital, pre-operation, and each 1, 3, 6, 12, 24, 36-month after surgery.
Short-term outcomes and prognosis will be compared between frailty group and non-frailty group. In addition, we clarify the impact of frailty and sarcopenia on prognosis among these patients.

Registered date

2020

Year

12

Month

06

Day

Last modified on

2023

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048684