UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045820 |
|---|---|
| Receipt number | R000052312 |
| Scientific Title | A Database Study to evaluate the Effect of Cancer Cachexia (Weight loss) on Anti-Cancer Drug in Patients with Pancreatic Cancer who receive the first line Chemotherapy |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2024/03/25 14:17:17 |
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Basic information
Public title
A Database Study to evaluate the Effect of Cancer Cachexia (Weight loss) on Anti-Cancer Drug in Patients with Pancreatic Cancer who receive the first line Chemotherapy
Acronym
A Database Study to evaluate the Effect of Cancer Cachexia (Weight loss) on Anti-Cancer Drug in Patients with Pancreatic Cancer
Scientific Title
A Database Study to evaluate the Effect of Cancer Cachexia (Weight loss) on Anti-Cancer Drug in Patients with Pancreatic Cancer who receive the first line Chemotherapy
Scientific Title:Acronym
Database Study to evaluate the Effect of Cancer Cachexia (Weight loss) on Anti-Cancer Drug in Patients with Pancreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of cancer cachexia on the duration of first-line chemotherapy for pancreatic cancer
Basic objectives2
Others
Basic objectives -Others
Understanding the relationship between the presence or absence of cancer cachexia and chemotherapy treatment
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence/absence of discontinuation/completion of initial chemotherapy (1st line) and number of days until that
Key secondary outcomes
Presence/absence of discontinuation/completion of initial chemotherapy (1st line) and the number of drug prescriptions before that
Overall Survival (OS)
etc
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with pancreatic cancer
Patients who received FOLFIRINOX or GEM + nabPTX as initial chemotherapy
Patients who have 2 body weight data recorded: body weight data as of the start date of the first chemotherapy and body weight data that exist 6 months (183 days) prior to the start of the first chemotherapy
Key exclusion criteria
Pancreatic cancer stage < 3 on the first day of initial chemotherapy
Patients who received initial chemotherapy < 60 days followed by surgery
Patients who have undergone surgery for pancreatic cancer between the most recent diagnosis of pancreatic cancer and the start of initial chemotherapy.
Relapsed patients without initial surgery
Relapsed patients without initial information
Relapsed patients without initial postoperative chemotherapy
Recurrence less than 183 days after completion of initial postoperative chemotherapy
Patients with recurrent pancreatic cancer of stage 3 or higher at the initial onset who have received preoperative chemotherapy for at least 60 days
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical, Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-Chome Chuo-ku, Tokyo
TEL
03-5640-3711
hi.matsumoto@ono-pharma.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Machii |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical, Medical Affairs
Zip code
541-8564
Address
8-2,Kyutaromachi1-chome Chuo-ku,Osaka-shi 541-8564,Japan
TEL
06-6263-5670
Homepage URL
machii@ono-pharma.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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ONO PHARMACEUTICAL CO., LTD.
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-5670
n.nishiwaki@ono.co.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
| 2021 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
https://site2.convention.co.jp/jsmo2023/program/Program03.pdf
Publication of results
Published
Result
URL related to results and publications
https://site2.convention.co.jp/jsmo2023/program/Program03.pdf
Number of participants that the trial has enrolled
1897
Results
Cancer cachexia was tended to be associated with shorter TTF and reduced number of doses in patients with pancreatic cancer who received first-line chemotherapy
Results date posted
| 2023 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 18 | Day |
Baseline Characteristics
-
Participant flow
-
Adverse events
none
Outcome measures
Time to treatment failure (TTF)
Number of doses
Overall survival(OS)
Relative dose intensity (RDI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the MDV database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052312
