UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035002
Receipt No. 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 (Ver. 5)

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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
Institute ONO PHARMACEUTICAL CO., LTD.
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039808