UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033693
Receipt number R000038416
Scientific Title A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients
Date of disclosure of the study information 2018/08/10
Last modified on 2020/09/27 14:39:56

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Basic information

Public title

A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients

Acronym

A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients

Scientific Title

A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients

Scientific Title:Acronym

A retrospective cohort study to investigate the incidence of cachexia in gastric cancer patients

Region

Japan


Condition

Condition

Gastric Cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the frequency of onset and the time to onset of cancer cachexia by a retrospective cohort study, in patients who were diagnosed with unresectable advanced gastric cancer for the first time and underwent systemic chemotherapy.

Basic objectives2

Others

Basic objectives -Others

Retrospective observation study

Trial characteristics_1


Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The frequency of onset and the time to onset of cancer cachexia in patients who were diagnosed with unresectable advanced gastric cancer for the first time and underwent systemic chemotherapy

Key secondary outcomes

1) Relationship between onset of cancer cachexia and changes in laboratory parameter
2) Relationship between cancer cachexia and overall survival
3) Relationship between cancer cachexia and the continuation rate of anticancer chemotherapy
4) Relationship between cancer cachexia and the introduction rate of secondary therapy
5) Relationship between onset of cancer cachexia and introduction rate of tertiary therapy
6) Relationship between cancer cachexia and severity and incidence of anorexia and fatigue
7) Correlation between the changes in body weight of >= 5% (or if BMI < 20, changes in body weight of >2%) and changes in each laboratory parameter during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systemic chemotherapy


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who satisfy all the following items are included.
1) Patients diagnosed with progressive gastric cancer that cannot be resected radically
2) Patients who were measured body weight periodically at the time of visit and during the subsequent medical consultation period
3) Received cancer chemotherapy during the study period

Key exclusion criteria

Patients who meet at least one of the following exclusion criteria are not included.
1) Patients who underwent surgical operation of the gastrointestinal tract within the last 6 months excluding stent placement in the gastrointestinal tract or gastroduodenostomy
2) Patients with weight loss distinctly caused by a gastrointestinal transit disorder
3) Patients with simultaneously active, double cancer (Stage I intraepithelial carcinoma, intramucosal carcinoma, superficial bladder carcinoma, or other cancers without recurrence for 5 years or more can be registered)
4) Patients with missing of weight data over 12 weeks at the time of visit and during the subsequent medical consultation period
5) Patients who underwent puncture for ascitic fluid at the beginning of initial systemic chemotherapy

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Machii

Organization

ONO PHARMACEUTICAL CO., LTD.

Division name

Section 2 Medical Planning I Medical Affairs

Zip code

541-0056

Address

8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi 541-8564, Japan

TEL

06-6263-2992

Email

machii@ono.co.jp


Public contact

Name of contact person

1st name Masaru
Middle name
Last name Fukahori

Organization

Kurume University Hospital

Division name

Multidisciplinary Cancer Treatment Center

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan

TEL

0942-31-7561

Homepage URL


Email

digdug0526@gmail.com


Sponsor or person

Institute

ONO PHARMACEUTICAL CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.

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

Ethics Committee of Kurume University

Address

67-Banchi, Asahi-machi, kurume-shi, Fukuoka

Tel

0942-31-7917

Email

sangaku@kurume-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



Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 10 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s00520-020-05479-w

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00520-020-05479-w

Number of participants that the trial has enrolled

131

Results

Incidence of WL was 53% at the first 12 weeks after starting first-line chemotherapy, and increased to 88% after 48 weeks. Overall survival rates were significantly associated with WL at 12, 24, and 48 weeks. Appetite loss and fatigue were more frequent and more severe in patients with WL.

Results date posted

2020 Year 09 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We searched medical record databases at the study centers to identify patients who were diagnosed with advanced gastric cancer and underwent first-line systemic chemotherapy between September 1, 2010, and August 31, 2016, at Kurume University Hospital and Shizuoka Cancer Center Hospital.

Participant flow

A total of 1032 patients with advanced gastric cancer were identified at our two institutions during the 6-year period. However, only 131 patients met the all inclusion criteria and were included in the study, and 901 were excluded, predominantly because body weight data were not available.

Adverse events

Not applicable

Outcome measures

Incidence of WL was 53% at the first 12 weeks after starting first-line chemotherapy,
and increased to 88% after 48 weeks.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 05 Month 23 Day

Date of IRB

2018 Year 12 Month 25 Day

Anticipated trial start date

2018 Year 08 Month 10 Day

Last follow-up date

2018 Year 08 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This retrospective cohort study is carried out on clinical data collected using the electronic data collection system (EDC) from the medical record of subjects. Patients who were initially diagnosed with advanced gastric cancer that cannot be resected radically prior to August 31, 2016 and who underwent systemic chemotherapy at the sites are included in the study. Patient enrolment is based on a definitive diagnosis in the medical record. The medical records are collected for at least 1 year (maximum 3 years) from the date of the initial systemic chemotherapy.

<Contents collected>
1) Baseline characteristics (At the time of initial systemic chemotherapy)
Age, birth year/month, sex, height, body weight, complications (COPD, diabetes, hypertension, dyslipidemia, hypothyroidism etc.), ECOG PS, primary lesion (gastroesophageal junction, gastric corpus, gastric antrum), pathological classification (tub1, tub2, por1, por2, pap, sig, muc, etc.), UICC staging, metastatic lesion (Lung, liver, bone, brain, distant lymph node, peritoneal metastasis etc.), laboratory parameter (Na, K, AST, ALT, AL-P, t-Bil, Neu, WBC, Plt, Cre, Alb, TLC, CRP, Hb), tumor marker (CA19-9, CEA), IVH, stoma (Ileum, colon), fatigue and anorexia
2) Clinical information collected every 4-week from the initial systemic chemotherapy
Body weight, ECOG PS, laboratory parameter, tumor marker, fatigue and anorexia, surgery related to the primary disease, severe ascites, IVH, stoma
3) Clinical information collected from all the consultation period
- Initial systemic chemotherapy [Regimen, initial/final date, reason for discontinuation, confirmation date of exacerbation, antitumor effect (RECIST ver1.1)]
- Secondary/tertiary chemotherapy and if not done, the reason (Regimen, initial/final date)
- Final outcome (Survival, death, lost to follow-up)


Management information

Registered date

2018 Year 08 Month 09 Day

Last modified on

2020 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name