UMIN-CTR Clinical Trial

Public title

An exploratory study on poor prognostic factors for patients with resected body-tail adenocarcinoma of the pancreas.

Acronym

Poor prognostic factors for pancreatic body-tail adenocarcinoma

Scientific Title

An exploratory study on poor prognostic factors for patients with resected body-tail adenocarcinoma of the pancreas.

Scientific Title:Acronym

Poor prognostic factors for pancreatic body-tail adenocarcinoma

Region

Japan

Condition

Pancreatic adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the poor prognostic factor of resected distal pancreatic cancer patients focusing on the extent of retropancreatic disease progression (RP) and other organ invasion (OO), and to re-considerate the resectability status and oncological outcome of distal pancreatic cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival (OS)

Key secondary outcomes

Disease free survival (DFS)
Poor prognostic factors for OS

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Pathologically proven pancreatic adenocarcinoma
2. Patients who underwent radical resection
3. Patients who accept to participate in this research

Key exclusion criteria

Patients judged inappropriate as research subjects by research managers

Target sample size

300

Name of lead principal investigator

1st name	Yasutoshi
Middle name
Last name	Kimura

Organization

Sapporo Medical University School of Medicine

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0608543

Address

S1, W16, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Email

kimuray@sapmed.ac.jp

Name of contact person

1st name	Yasutoshi
Middle name
Last name	Kimura

Organization

Sapporo Medical University School of Medicine

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

0608543

Address

S1, W16, Chuo-ku, Sapporo, Hokkaido

TEL

011-611-2111

Homepage URL

Email

kimuray@sapmed.ac.jp

Institute

Sapporo Medical University

Institute

Department

Personal name

Organization

Sapporo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Hokkaido Pancreatic Cancer study Group; HOPS

Name of secondary funder(s)

Organization

Institutional review board, Sapporo Medical University Hospital

Address

S1W16, Chuoku, Sapporo City

Tel

011-611-2111

Email

ko-hamaya-923@sapmed.ac.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

04

Month

27

Day

URL releasing protocol

http://sapmed-surg1.jp/gairai/optout.shtml

Publication of results

Partially published

URL related to results and publications

https://doi.org/10.1016/j.pan.2023.12.004

Number of participants that the trial has enrolled

322

Results

A multicenter retrospective study was conducted to comprehensively identify prognostic factors for pancreatic tail cancer. The maximum likelihood method identified 11 prognostic elements to stratify patients by oncological outcomes and emphasized its compensatory role over the conventional approach.

Results date posted

2024

Year

03

Month

11

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2023

Year

12

Month

06

Day

Baseline Characteristics

A total of 322 patients who underwent DP were registered to the HOPS Pt-01 cohort from 5 institutions. Of the initial 322 patients, 153 had tumors localized in the pancreatic body, 67 had tumors localized in the body to tail, and 1 patient presented with 2 separate lesions in the body and tail, respectively. Furthermore, among the patients with Pt-PC, one was excluded due to the presence of concurrent liver metastasis at the time of diagnosis. This patient underwent laparoscopic DP during multidisciplinary treatment that included hepatic arterial infusion chemotherapy. Conse- quently, 100 patients with Pt-PC were included in this retrospective nalysis. The distribution of study patients is presented in Table 1. The study patients predominantly consisted of males with a me- dian age of 69 years (range, 42e86). The median CA19-9 level was 55 U/mL (range, 0.6e2367.1). Regarding treatment period, there were 10 patients before 2007, 43 patients from 2008 to 2012, and 47 patients since 2013. The primary tumor location was the Pt in 97 patients. Three patients had tumors in the tail that extended slightly into the body (Ptb).

Participant flow

The maximum likelihood method (MLM) was employed to search for the optimal combination of factors influencing RFS or OS. Stepwise selection of variables using corrected Akaike's Informa- tion Criterion (AICc) and Bayesian Information Criterion (BIC) was performed to select the most appropriate covariance structure. Proportional hazards regression models were used to identify po- tential combinations of prognostic elements. Selection of prog- nostic elements for RFS was guided by AICc and BIC values. AICc and BIC are measures of the goodness of fit of a statistical model that take into account the number of model parameters. Lower AICc and BIC values indicate better model fit. Initially, we used the 25 ele- ments in the proportional hazards model to explore combinations of factor that minimize AICc and BIC values. During variable se- lection, we included variables deemed appropriate as explanatory variables based on previous reports and variables that were known to be confounders. We also prioritized factors with p < 0.01 in the Cox univariate analysis.
Independent prognostic factors for RFS and OS were further identified using a multivariate Cox proportional hazards regression model based on the factors for the most appropriate covariance structure. Statistical analyses were conducted using JMP Pro 16.0 software (JMP Japan, Tokyo, Japan) and SPSS version 26.0 (SPSS, Armonk, New York, USA).

Adverse events

No corresponding data available

Outcome measures

The survey consisted of 24 variables, including individual pa- tient demographic data, details on neoadjuvant treatment (NAT), details about attempted radical surgery, perioperative factors including surgical morbidities according to the Clavien-Dindo (CD) classification [13], pathological findings including pTNM stage [10], histologic assessment of the extent of preoperative treatment response according to the Evans grading system [14], adjuvant treatment (AT), and outcomes including, types of initial relapse, subsequent treatment, and death from any cause. CA19-9 values were recorded at the time of diagnosis. Postoperative nadirs, irre- spective of timing, were also recorded. AT was defined as complete if the prescribed treatment course was performed or based on the treating physician's decision to conclude it later. Overall patient survival (OS) was calculated from the date of surgery to the date of the last follow-up or patient death. Relapse-free survival (RFS) was calculated from the date of surgery to the date of the last follow-up or confirmation of recurrence. The first survey started in February 2019. Survival data were collected up until December 2021.
The primary objective was to identify the optimal combination of factors that affect relapse-free survival (RFS). The secondary outcomes were to evaluate the association of these factors with 5- year RFS and early relapse within 1 year, identify the independent prognostic factors among them, and reveal the characteristics of these factors in patients with 5-year RFS.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018

Year

04

Month

09

Day

Date of IRB

2018

Year

07

Month

04

Day

Anticipated trial start date

2018

Year

07

Month

05

Day

Last follow-up date

2019

Year

07

Month

31

Day

Date of closure to data entry

2019

Year

12

Month

31

Day

Date trial data considered complete

2020

Year

01

Month

31

Day

Date analysis concluded

2022

Year

03

Month

31

Day

Other related information

Background information: age, sex, medical history,
Tumor marker: CEA, CA19-9
Surgical information: operative method, operation time, amount of bleeding
Postoperative information: postoperative complication, postoperative hospital stay
Information on postoperative information: presence or absence of postoperative adjuvant chemotherapy (drug, duration) Presence or absence of recurrence (presence or absence of treatment, content, duration), presence / absence of death, cause of death

Registered date

2018

Year

04

Month

12

Day

Last modified on

2024

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036748