Surgery for Locally Unresectable Pancreatic Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera di Padova

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years

Patients able to give informed consent

Histologically confirmed pancreatic adenocarcinoma

LAPC stage according to NCCN10 at diagnosis (Figure 1)

Disqualifiers

Informed consent withdrawal

Presence of tumor characteristics precluding surgery

Presence of patient significant comorbidities precluding surgery

Unavailable pre-induction therapy abdominal imaging

Trial population

Patient with hystologically proved locally advanced pancreatic adenocarcinoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Disease-specific survival (DSS)

Time frame
2 year from enrollment
2

Recurrence-free survival (RFS)

Time frame
2 year from enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera di Padova

Lead sponsor

University of Padova

Collaborator