Surgery for Locally Unresectable Pancreatic Cancer (ROBIN)

November 21, 2025 updated by: Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Conversion Surgery for Locally Unresectable Pancreatic Cancer - International Multi-center Observational Trial (ROBIN= suRgery for lOcally unresectaBle pancreatIc Cancer)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic cancer (PC) has a rising incidence and remains associated with one of the mostchallenging prognosis in oncology, with a 5-years survival around 11% and merely 4% of patients alive at 10 years. About one third of PC patients is diagnosed with locally advanced (LAPC) stage of disease, with a primary tumor that is considered unresectable (in the absence of metastatic disease) due to the local involvement of major vessels and is typically treated with palliative chemotherapy or best supportive care, with the aim to prolong survival while maintaining acceptable quality of life (QoL). However, the introduction of novel induction chemotherapy regimens has improved the clinical outcome of these patients in recent years. The preferred induction regimen for patients with favorable performance status (ECOG 0-1) has become modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin [(m)FOLFIRINOX], with gemcitabine + nab-paclitaxel (GEMNabP) as a more tolerable alternative. In this scenario, the resection of apparently unresectable PC following induction chemotherapy, although somewhat controversial, has emerged as an important development for selected patients. In this regard, the National Comprehensive Cancer Network (NCCN) guidelines recommends 4 to 6 months of induction combination chemotherapy followed by conventional radiotherapy (CRT) or stereotactic body radiation therapy (SBRT) for selected patients without systemic metastases, followed by consideration for surgical resection if feasible, with adjuvant chemotherapy if clinically indicated. Surgical resection can be usually achieved in about 25% of LAPC patients after chemotherapy with modern regimens, and in the context of multidisciplinary management at high-volume centers with high expertise. Resection is associated with encouraging results in terms of median overall survival (OS), reaching 20 to 40 months, and with 5-years survival around 20%. To achieve surgical radicality, venous resection, arterial divestment or even arterial resection could be necessary. In recent multicentric series, patients receiving R0 portal vein (PV)/superior mesenteric vein (SMV) resection had a median OS of 24 months and a 20% 5-year OS 16, and patients requiring major arterial reconstruction and/or periarterial divestment had in-hospital mortality rates of 4-5%, median OS of 13.7-20.1 months, and 5-year OS of 12.5-13.7%. Despite the encouraging survival outcomes, based on both remarkable advances in surgical technique at high-volume centers and the use of modern combination chemotherapy regimens and chemo-radiation, aggressive surgery for LAPC after induction chemotherapy remains a controversial topic for several aspects:

  • Most of the available literature consists of retrospective studies, without intention-to-treat design and with clear selection bias for best responders after induction therapy, who are selected for surgery. Other studies reported similar survival outcomes in non-resected LAPC patients who had a good radiographic and serologic response after first line chemotherapy. While standard dose RT appeared ineffective in patients who have not undergone resection, RT with dose intensification and ablative intent might enable improvements in local control in LAPC patients, and SBRT seems to successfully achieve local control while also improving QoL.
  • Most series considered locally advanced and borderline resectable PC as a single entity or did not distinguish between arterial resection of common hepatic artery (CHA)/celiac trunk (CA) or superior mesenteric artery (SMA), despite clear differences in terms of prognosis and perioperative complexity. Surgery for LAPC is feasible and safe only at high-volume centers with dedicated programs, and arterial resections are technically demanding procedures with a long learning curve (esteemed around 15 procedures).
  • Quality of life (QoL) and patient reported outcomes (PROMS) were seldom verified and put in the context of the relatively modest survival of resected LAPC patients. Despite improvements in recent years, arterial divestment or resections may not only increase significantly perioperative morbidity and mortality, but also imply life-long consequences such as diarrhea, due to nerve plexus dissection, and diabetes, as total pancreatectomy is often required. Despite its technical complexity, there is no high-level evidence supporting the benefit of aggressive surgery for LAPC after induction chemotherapy.

The aim of the present study is to evaluate survival and QoL outcomes in a cohort of patients affected by LAPC and selected for surgical exploration and radical resection after disease non progression during induction chemotherapy at leading expert centers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy
        • Recruiting
        • UOC Chirurgia Generale 2, Azienda Ospedale di Padova, Padova, Italy 35128
        • Contact:
        • Contact:
        • Principal Investigator:
          • Umberto Cillo, MD, Director, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with hystologically proved locally advanced pancreatic adenocarcinoma

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HRQoL deterioration-free survival
Time Frame: From enrollment to the end of study period, set at 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease-specific survival (DSS)
Time Frame: 2 year from enrollment
2 year from enrollment
Recurrence-free survival (RFS)
Time Frame: 2 year from enrollment
2 year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera di Padova

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOP3371
  • 6096/AO/24 (Other Identifier: CET area centro-est Veneto)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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