UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034265 |
|---|---|
| Receipt number | R000039030 |
| Scientific Title | The prospective observational study of non-surgical treatment for elderly patients with unresectable pancreatic cancer |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/09/28 11:56:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prospective observational study of non-surgical treatment for elderly patients with unresectable pancreatic cancer
Acronym
The prospective observational study of non-surgical treatment for elderly patients with unresectable pancreatic cancer
Scientific Title
The prospective observational study of non-surgical treatment for elderly patients with unresectable pancreatic cancer
Scientific Title:Acronym
The prospective observational study of non-surgical treatment for elderly patients with unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Geriatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to assess the current status of non-surgical treatments for 76 years old or older patients with pancreatic cancer which is not applicable for surgery, and clarify problems for the future.
Basic objectives2
Others
Basic objectives -Others
To clarify the problems for future trials
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of Grade 4 hematological adverse event and Grade 3-4 non-hematological adverse event
Key secondary outcomes
Treatment delay, skip and emergent admission until 3-months after the registration, progression-free survival, response rate, geriatric assessment after 3-months of treatment initiation, overall survival
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
| 76 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Key eligibility criteria were as follows:
1) Age >=76 years old at the registration
2) Diagnosed as invasive ductal carcinoma of pancreas by clinical or radiological findings
3) Diagnosed as cancer by the histopathological or cytological findings
4) Without history of radiotherapy or chemotherapy for pancreatic cancer
5) Out of the indication for curative surgery, or without willing of curative surgery
6) Able to receive evaluation of geriatric assessment
7) written informed consent
Key exclusion criteria
Not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ishii |
Organization
Chiba Cancer Center
Division name
Clinical Research Center
Zip code
260-8717
Address
666-2, Nitonacho, Chuo-ku, Chiba city
TEL
043-264-5431
hirishii@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Kanagawa Cancer Center
Division name
Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division
Zip code
241-0815
Address
2-3-2, Nakao, Asahi-ku, Yokohama city
TEL
045-520-2222
Homepage URL
kobayashis@kcch.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kanagawa Cancer Center
Address
2-3-2, Nakao, Asahi-ku, Yokohama City, Japan
Tel
045-520-2222
chiken-jimu4@kcch.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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35946841/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35946841/
Number of participants that the trial has enrolled
233
Results
In the propensity score-matched analysis, 42 patients each were selected from the GnP and Gem groups. The median OS was longer in the GnP group than in the Gem group (12.2 vs. 9.4 months; hazard ratio [HR], 0.65; 95% CI, 0.37-1.13). The median PFS was significantly longer in the GnP group than in the Gem group (9.2 vs. 3.7 months; HR, 0.38; 95% CI, 0.23-0.64).
Results date posted
| 2022 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the report on the Oncologist journal.
Participant flow
See the Figure 1 in the report on the Oncologist journal.
Adverse events
Neutropenia Grade 4: GnP, 23%; GEM,7.7%
Outcome measures
OS, PFS, safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Geriatric assessmment will be evaluated at the time of registration and 3months after.
Management information
Registered date
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039030
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/27 | GnP多施設前向き観察研究Ver1.1.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/09/27 | ⑧効果・生存情報報告用紙.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/09/27 | 76歳以上高齢者膵癌前向き観察研究（ご送付用20201228 ).xlsx |
