UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Pancreatic Cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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 invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy.

Basic objectives2

Others

Basic objectives -Others

Retrospective observation study

Trial characteristics_1

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The frequency of onset and the time to onset of cancer cachexia, in patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment 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 kg/m2 or sarcopenia) weight loss 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 systematic chemotherapy.
8) Correlation between the changes in body weight of >= 5% or (if BMI> 20 kg/m2 or sarcopenia) weight loss of > 2% and the severity and incidence of adverse event (neutropenia, anemia, thrombocytopenia, febrile neutropenia, anorexia, nausea, diarrhea, fatigue, peripheral sensory neuropathy, skin rash) during the first systemic chemotherapy period at 12-week intervals evaluated from the beginning day of the first systemic chemotherapy.
9) The results of primary and secondary endpoints are stratified by the regimen of initial systemic chemotherapy.

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

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 who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy
2) Patients who have pathologic diagnosis that is consistent with invasive pancreatic ductal carcinoma
3) Patients who were measured body weight periodically at the beginning of the initial systemic chemotherapies and during the subsequent medical consultation period
4) Received one of the following cancer chemotherapies during the study period
- mFOLFIRINOX
- GEM+nab-PTX
- GEM
- GEM+ERL
5) Patients who have not refused secondary use of the clinical information, or participated in the 19-075 Study, the K2011-001 Study, and 2012-0281 Study conducted at the National Cancer Center Hospital East and agreed to secondary use of the existing information

Key exclusion criteria

Patients who meet at least one of the following exclusion criteria are not included.
1) Patient who underwent surgical operation of the gastrointestinal tract within the last 6 months starting from the beginning day of the first systemic chemotherapy excluding stent placement in the duodenum or gastrojejunostomy
2) 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)
3) Patients with missing of body weight data over 12 weeks in the medical consultation period after the beginning of initial systemic chemotherapy
4) Patients who underwent puncture for ascitic fluid at the beginning of initial systemic chemotherapy

Target sample size

150

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

541-8564

Address

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

TEL

06-6263-2992

Email

machii@ono.co.jp

Name of contact person

1st name	Shuichi
Middle name
Last name	Mitsunaga

Organization

National Cancer Center Hospital East

Division name

Department of Hepatobiliary and Pancreatic Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shi, Chiba-ken, 277-8577 Japan

TEL

04-7133-1111

Homepage URL

Email

smitsuna@east.ncc.go.jp

Institute

ONO PHARMACEUTICAL CO., LTD.

Institute

Department

Personal name

Organization

ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of National Cancer Center

Address

1-1, Tsukiji 5-chome, Chuo-ku, Tokyo , Japan

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

26

Day

URL releasing protocol

https://link.springer.com/article/10.1007/s00520-020-05346-8

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007/s00520-020-05346-8

Number of participants that the trial has enrolled

150

Results

A total of 150 patients were registered. Base cachexia occurred in 50% of patients. Follow-up cachexia occurred in 32% within 12 weeks of starting first-line chemotherapy, reaching 64% at 1 year. Overall survival was not significantly different between patients with and without follow-up cachexia. Appetite loss, fatigue, nausea, and diarrhea were more frequent in patients with follow-up cachexia than in those without follow-up cachexia.

Results date posted

2020

Year

05

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

02

Month

26

Day

Baseline Characteristics

A total of 150 patients were registered. The median age and BMI were 65 years and 21.7 kg/m2, respectively.

Participant flow

Not applicable

Adverse events

Not applicable

Outcome measures

Not applicable

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

10

Month

02

Day

Date of IRB

2018

Year

11

Month

09

Day

Anticipated trial start date

2018

Year

11

Month

26

Day

Last follow-up date

2018

Year

11

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This retrospective observational study is carried out on clinical data collected using the EDC from the medical record of subjects. Patients who were diagnosed with invasive pancreatic ductal carcinoma with local progression or distant metastasis before the first treatment and underwent systemic chemotherapy at the site by 31 March 2017 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, the heaviest body weight in the last 6 months from the beginning day of the first systemic chemotherapy, complications , ECOG PS, primary lesion (pancreatic head, body, and tail), UICC staging, ascites, laboratory parameter (Na, K, AST, ALT, AL-P, t-Bil, Neu, WBC, Plt, Cre, Alb, TP, TLC, CRP, Hb, ChE, Glu), tumor maker (CA19-9), CTL3-SMI, Anorexia, fatigue, adverse events (Neutropenia, febrile neutropenia, anemia, platelet count reduction, nausea, diarrhea, peripheral sensory neuropathy, and rash) at the beginning of initial systemic chemotherapy
2) Clinical information collected every 4-week from the initial systemic chemotherapy
Body weight
3) Clinical information collected every 12-week from the initial systemic chemotherapy
ECOG PS, laboratory parameter, tumor maker, CTL3-SMI, anorexia, fatigue, adverse events during the initial systemic chemotherapy
4) Clinical information collected from all the consultation period
- Initial 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)

Registered date

2018

Year

11

Month

22

Day

Last modified on

2020

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039876