Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?

NCT06921252 | Completed DMC

• 1 other identifier: Kochi University
• Study Type: observational
• Target: 276
• Locations: 0 countries
• Sites: N/A

Brief Summary

The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Thus, whether Rec-PC and PM-PC should be included in the same category when conducting clinical trials evaluating chemotherapy remains controversial. The purpose of this study is to investigate the difference of overall survival (OS) between Rec-PC and PM-PC, and analyze their impact on prognosis.

Conditions

Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of evaluation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (2)

chemotherapy for metastatic pancreatic cancer

chemotherapy

Drug: chemotherapy agents

chemotherapy for recurrent pancreatic cancer

postoperative chemotherapy

Drug: chemotherapy agents

Interventions

chemotherapy agents DRUG

Overall, data of 276 patients (144 men and 132 women, 224 Rec-PC and 51 PM-PC) were retrospectively analyzed. The median patient age was 70 (range; 29-91) years. Serum carbohydrate antigen (CA) 19-9 among Rec-PC group (median; 207 U/mL) and PM-PC group (median; 1680 U/mL) was statistically different. Rec-PC patients received gemcitabine plus nab-paclitaxel (106), S-1 (37), gemcitabine (22), FOLRIFINOX (18) and other (8) regimen as a first line chemotherapy. 67 Rec-PC patients underwent any local treatment. PM-PC patients received gemcitabine plus nab-paclitaxel (34), FOLRIFINOX (8), gemcitabine (5), S-1 (2) and other (2) regimen as a first line chemotherapy.

chemotherapy for metastatic pancreatic cancer; chemotherapy for recurrent pancreatic cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A retrospective database review of patients with recurrent or primary metastatic pancreatic cancer at a single institution, from 2010 to 2023, was conducted.

You may qualify if:

• unresectable pancreatic cancer

You may not qualify if:

• Patients expected to survive for less than three months

Sponsors & Collaborators

• Kochi University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 10, 2025
• Study Start: January 1, 2010
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share