UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035002
Receipt number R000039808
Scientific Title A retrospective cohort study to investigate the incidence of cachexia in colorectal cancer patients
Date of disclosure of the study information 2018/11/27
Last modified on 2020/11/09 14:41:10

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Colorectal 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 colorectal cancer for the first time and underwent systemic chemotherapy

Basic objectives2

Others

Basic objectives -Others

Retrospective observation study

Trial characteristics_1

Others

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 colorectal 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 colorectal 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 colostomy
and stent placement in the gastrointestinal tract
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 Eiji
Middle name
Last name Kasamatsu

Organization

ONO PHARMACEUTICAL CO., LTD.

Division name

Medical Planning I

Zip code

541-8564

Address

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

TEL

662632992

Email

e.kasamatsu@ono.co.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Hamauchi

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture 411-8777 Japan

TEL

055-989-5222

Homepage URL


Email

s.hamauchi@scchr.jp


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

Exploratory Research Ethics Review Committee, Shizuoka Cancer Center

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture Japan

Tel

055-989-5222

Email

tansaku_office@scchr.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

静岡県立静岡がんセンター(静岡県)
久留米大学病院がん集学治療センター(福岡県)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 27 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s12325-020-01516-6

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s12325-020-01516-6

Number of participants that the trial has enrolled

150

Results

Cumulative incidence of cancer cachexia was 50.7% at 24 weeks, and reached 91.3% over the whole study period. OS was significantly different between patients with and without cancer cachexia within 24 weeks after starting first-line treatment, although the onset of cancer cachexia within 24 weeks could not be considered as an independent prognostic factor for OS. Severe appetite loss and fatigue tended to occur more frequently in patients with cancer cachexia within 24 weeks.

Results date posted

2020 Year 11 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 10 Month 16 Day

Baseline Characteristics

A total of 150 patients (90 men and 60 women) were registered in this study Median age and BMI were 65 years (range 29-85) and 21.7 kg/m2 (14.8-32.5), respectively. The proportions of patients with ECOG PS0, PS1, and PS2 were 50.0%, 43.4%, and 6.0%, respectively. Primary tumor sites were rectum (60.0%) and colon (40.0%), and most patients had stage IV cancer (99.3%).

Participant flow

Medical records databases were searched to retrieve the records of patients who were diagnosed with advanced colorectal cancer with local progression or distant metastasis and who underwent first-line systemic chemotherapy for advanced colorectal cancer between February 1, 2010 and August 31, 2016 at Shizuoka Cancer Center Hospital and Kurume University Hospital.

Adverse events

Not applicable

Outcome measures

Cumulative incidence of cancer cachexia was 50.7% at 24 weeks, and reached 91.3% over the whole study period. OS was significantly different between patients with and without cancer cachexia within 24 weeks after starting first-line treatment, although the onset of cancer cachexia within 24 weeks could not be considered as an independent prognostic factor for OS. Severe appetite loss and fatigue tended to occur more frequently in patients with cancer cachexia within 24 weeks.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 15 Day

Date of IRB

2018 Year 11 Month 20 Day

Anticipated trial start date

2018 Year 11 Month 27 Day

Last follow-up date

2018 Year 11 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This retrospective observational 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 progressive colorectal 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 (Rectum, colon), 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, anorexia and fatigue, 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 11 Month 26 Day

Last modified on

2020 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name