Surgery for Locally Unresectable Pancreatic Cancer

NCT07241663 | Recruiting

• 2 other identifiers: AOP33716096/AO/24
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is a severe disease often diagnosed at an advanced stage, when surgery is not possible. New chemotherapy treatments can sometimes shrink the tumor and make surgery an option. This study aims to understand if surgery after such treatments can improve survival and quality of life in selected patients treated at expert centers.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer; Coversion Surgery Pancreatic Cancer; Quality of Life; Locally advanced PDAC; Unresectable Pancreatic Cancer; Neoadjuvant therapy for pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• HRQoL deterioration-free survival

  The primary outcome is HRQoL deterioration-free survival, defined as the time from surgery until definite HRQoL score deterioration and including death from any cause as an event.

  From enrollment to the end of study period, set at 2 years

Secondary Outcomes (2)

• Disease-specific survival (DSS)

  2 year from enrollment

• Recurrence-free survival (RFS)

  2 year from enrollment

Interventions

Questionnaire OTHER

Each enrolled patient will complete quality of life questionnaires, specifically the EORTC QLQ-C30, PAN26, and EQ-5D, at different time points: at enrollment and every 2-3 months after surgery, for up to 2 years.

Eligibility Criteria

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

Study Population

Patient with hystologically proved locally advanced pancreatic adenocarcinoma

You may qualify if:

• Patients older than 18 years
• Patients able to give informed consent
• Histologically confirmed pancreatic adenocarcinoma
• LAPC stage according to NCCN10 at diagnosis (Figure 1)
• Received at least 4 months of induction chemotherapy
• RECIST 1.1 stable disease (SD) or partial response (PR) after induction therapy
• Patient considered eligible for radical resection by local MDT

You may not qualify if:

• Informed consent withdrawal
• Presence of tumor characteristics precluding surgery
• Presence of patient significant comorbidities precluding surgery
• Unavailable pre-induction therapy abdominal imaging
• Pathological confirmation of any tumor different from PDAC

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead
• University of Padova: collaborator

Study Sites (1)

UOC Chirurgia Generale 2, Azienda Ospedale di Padova, Padova, Italy 35128

Padua, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery 2 Department - HBP and liver transplantion unit

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)