UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035668 |
|---|---|
| Receipt number | R000040633 |
| Scientific Title | Cohort study of patients with initially unresectable pancreatic cancer in whom conversion surgery is planned after FOLFIRINOX or gemcitabine plus nab-paclitaxel therapy |
| Date of disclosure of the study information | 2019/01/26 |
| Last modified on | 2022/02/02 14:08:04 |
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Basic information
Public title
Cohort study of patients with initially unresectable pancreatic cancer in
whom conversion surgery is planned after FOLFIRINOX or gemcitabine
plus nab-paclitaxel therapy
Acronym
PC-CURE-1
Scientific Title
Cohort study of patients with initially unresectable pancreatic cancer in
whom conversion surgery is planned after FOLFIRINOX or gemcitabine
plus nab-paclitaxel therapy
Scientific Title:Acronym
PC-CURE-1
Region
| Japan | Asia(except Japan) |
Condition
Condition
Unresectable 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 prognosis of patients who underwent conversion surgery,
with tumors' being evaluated as resectable after FOLFIRINOX or GnP
therapies for unresectable pancreatic cancer, and factors influencing the
prognosis in a retrospective study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival from the day when resection was considered to be
possible (day of examination)
Key secondary outcomes
Relapse-free survival, post-resection survival, mode of relapse, presence
or absence of hospital death, and surgery-related complications
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
1. Patients with initially pathological confirmed adenocarcinoma and
consitent with pancreatic ductal adenocarcinoma including papillary
adenocarcinoma, tubular adenocarcinoma, poor differentiated
adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging
2. Locally advanced or distant metastatic disease before starting of
chemotherapy
3. FOLFIRINOX (including modified regimen) or gemcitabine plus
nab-paclitaxel initially performed
4. Diagnosed as resectable disease after chemotherapy by imaging, then
laparotomy or continuation of chemotherapy performed
Key exclusion criteria
1. Borderline resectable disease by NCCN Guidelines Ver 2.2018 is
excluded in this study. Solid tumor contact with the CA >180 degrees is
classified to unrsectable.
2. Recurrent disease
3. Response to chemotherapy according to RECIST ver 1.1 was PD
4. Heavy ion radiotherapy or proton beam therapy performed before
laparotomy
5. Diagnosed as unresectable disease by examination laparoscopic when
was intented to conversion surgery
6. Resection of metastatic lesions at conversion surgery. However, patients can be registered unless they are pathologically demonstrated to have
cancer after dissection of the 16th lymph node or hepatectomy.
7. Peritoneal lavage cytology positive
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Furuse |
Organization
Kyorin University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
jfuruse@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Sakurai |
Organization
Federation of Asian Clinical Oncology (FACO)
Division name
Tokyo Office
Zip code
101-0061
Address
Tki Bldg. 2F, 3-3-1, Kanda-Misakicho, Chiyoda-ku, Tokyo
TEL
03-5542-0546
Homepage URL
faco-office@jsco.or.jp
Sponsor or person
Institute
Federation of Asian Clinical Oncology (FACO)
Institute
Department
Personal name
Funding Source
Organization
Federation of Asian Clinical Oncology (FACO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University Faculty of Medicine Institutional Review Board
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
irb@ks.kyorin-u.ac.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
| 2019 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Period during the day when resection was considered to be possible:
January 1, 2014 to December 31, 2018
Data collection
1) Patient background before chemotherapy and preoperative information
Patient background: Age, sex, and ECOG performance status
Tumor status: Reasons why resection is impossible, UICC Stage TNM 7th edition, primary focus site of the pancreas, size of the primary focus, presence or absence of arterial invasion, presence or absence of portal invasion, regional lymph node metastasis, distant metastasis and sites of metastasis, tumor markers (CEA, CA19-9), and presence or absence of biliary drainage
2) Chemotherapy
Date of chemotherapy initiation, regimen, chemotherapy duration, Evaluation of the chemotherapy response (RECIST ver. 1.1), and presence or absence of (simultaneous or sequential) radiotherapy
3) Reasons why laparotomy was not done
4) Information immediately before surgery
ECOG performance status, UICC Stage TNM 7th edition, presence or absence of arterial invasion, presence or absence of portal invasion, regional lymph node metastasis, tumor markers (CEA, CA19-9), and interval from the completion of chemotherapy until surgery
4) Surgical information
Date of surgery, resection technique (PD, DP, total PE, DP-CAR), organs to be resected, pathological diagnosis, degree of curability, EVANS classification, presence or absence of hospital death, and presence or absence of serious complications (Clavien-Dindo classification: grade IIIa or higher)
If unresectable at the laparotomy, the reasons
6) Follow-up survey: 6 months after the completion of registration
Survival or death, final day of confirmation, presence or absence of relapse/date of confirmation, pattern of relapse, and presence or absence of postoperative adjuvant therapy/regimen
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040633
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