Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver

NCT06690528 | Recruiting Phase 2

• 2 other identifiers: University of Padova, Italy23170
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the impact of surgical resection compared to palliative care in patients with oligometastatic pancreatic cancer limited to the liver. Specifically, it examines whether surgery after stable disease or response to chemotherapy can improve survival and quality of life. The international, multicenter randomized trial will recruit 56 patients, assigning them to either surgical resection (including tumor and liver metastases) or ongoing palliative care with chemotherapy. Stratification by performance status, tumor markers, and tumor location will ensure balanced study groups. Outcome assessments, conducted over a minimum two-year follow-up, include clinical evaluations, imaging, and quality-of-life metric

Conditions

Pancreatic Cancer Metastatic

Keywords

Pancreatic Cancer Metastatic to Liver; Pancreatic Cancer Oligometastatic to Liver; Coversion Surgery Pancreatic Cancer; NEoadiuvant Therapy for Oligometastatic Pancreatic Cancer; Resectable Pancreatic Cancer; Resectable Liver Metastasis in Pancreatic Cancer; Combined Surgery for Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Two-year OS (2y-OS) rate

  The percentage of patients alive after 2 years from randomization.

  2 years from randomization.

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Surgical mortality and morbidity

  90 days after surgery.

• Cancer Quality of Life (CQoL)

  From date of randomization up to 2 years. The frequency of evaluations may vary depending on the study phase it will generally occur every 8-12 weeks according to clinical practice.

• Pancreatic Cancer Quality of Life (PQoL)

  From date of randomization up to 2 years. The frequency of evaluations may vary depending on the study phase it will generally occur every 8-12 weeks according to clinical practice.

• Treatment-related Adverse Event

  From date of randomization up to 2 years.

Study Arms (2)

Surgical Resection Arm

EXPERIMENTAL

Patients in this arm will undergo surgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation/microwave on the liver lesions is possible for lesions \<20 mm if technically feasible. Post-operative chemotherapy and/or radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.

Procedure: Surgical resection of both the primary tumor and liver metastases

Palliative care arm

NO INTERVENTION

Patients in this arm will continue to be treated following palliative care, consisting in observation or continuation of chemotherapy according to investigator's choice and duration of first-line chemotherapy. If required, they will continue with systemic chemotherapy, as received during the initial treatment phase, with a chemotherapy protocol based on the Institution's approved guidelines and adjusted as for clinician's choice.

Interventions

Surgical resection of both the primary tumor and liver metastases PROCEDURE

Surgical resection of both the primary tumor and liver metastases. The surgical approach, extent of resection, and perioperative management will follow the standard protocols at each participating center. Venous vascular resections might be performed to reach radicality. Either standard or parenchyma sparing liver resections might be performed for resection of the liver metastases. Alternatively, needle ablation/microwave on the liver lesions is possible for lesions \<20 mm if technically feasible. Post-operative chemotherapy and/or radiotherapy could be administered as per multi-disciplinary decision based on case-by-case evaluation.

Surgical Resection Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged ≥18 years and ≤75 years (at diagnosis).
• Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5).
• Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions).
• No evidence of extrahepatic metastases (at diagnosis.)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment)
• Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment).
• Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment).
• Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation/microwave once no larger than 20 mm (at enrollment).

You may not qualify if:

• Locally advanced pancreatic cancer according to NCCN4.
• Unresectable liver disease (according to multidisciplinary discussion).
• Involvement of other organs.
• Presence of significant comorbidities precluding surgery.
• Pregnancy.
• Contraindications to surgical resection.
• Prior surgical resection of the primary tumor or liver metastases.
• Evidence of extrahepatic metastases.
• Inability to provide informed consent or participate in follow-up assessments.
• Disease progression as determined by RECIST 1.1 criteria21 (modified to include any % of increase in the sum of diameters of target lesions) after chemotherapy.
• Serum CA19-9 level increase \>20% after chemotherapy.

Sponsors & Collaborators

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

Study Sites (1)

UOC Chirurgia Generale 2, Azienda Ospedale di Padova

Padua, Italy, 35128, Italy

RECRUITING

Related Publications (1)

• Guastella R, Perri G, Bassi D, Canitano N, Padoan V, Grandi S, Pellegrini R, Procaccio L, Bergamo F, Lonardi S, Carandina R, Gringeri E, Marchegiani G, Cillo U. Conversion surgery vs. standard of care in pancreaTic cancer oligometastatic to the liver (SONAR: Surgery in Oligometastatic paNcreatic cAnceR) a randomized controlled trial. BMC Cancer. 2026 Jan 12;26(1):44. doi: 10.1186/s12885-025-15183-9.

  PMID: 41526867 DERIVED

Study Officials

• Giovanni Marchegiani, MD, PhD, Professor

  University of Padova

  STUDY CHAIR

• Umberto Cillo, Director, MD, Professor

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Marchegiani, Medical Doctor, PhD, Professor

CONTACT

+390498212259; giovanni.marchegiani@unipd.it

Giampaolo Perri, Medical Doctor

CONTACT

+390498212259; giampaolo.perri@unipd.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Surgery 2 Department - HBP and liver transplantion unit

Model Details: This is a phase-2 multicenter randomized controlled trial with a 1:1 allocation ratio. Eligible patients with pancreatic cancer oligometastatic to the liver with response/stability after first-line chemotherapy will receive surgical resection or observation/continued chemotherapy. The study will be conducted at different international referral centers with high expertise in pancreatic cancer treatment to ensure the highest standards of quality and an adequate sample size. After the enrollment of the first 20 cases, an independent data monitoring committee (IDMC) will review safety and futility (using 90 days major morbidity + mortality as the endpoint), to allow for early study termination or modification if necessary.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 15, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)