Surgery after tumor-shrinking treatment for locally advanced pancreatic cancer
Conversion Surgery for Locally Unresectable Pancreatic Cancer - International Multi-center Observational Trial (ROBIN= suRgery for lOcally unresectaBle pancreatIc Cancer)
This project will test whether doing surgery after at least four months of chemotherapy helps people with locally advanced pancreatic cancer that was initially considered not removable live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Padova) |
| Trial ID | NCT07241663 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort of patients with locally advanced pancreatic adenocarcinoma treated at expert centers who receive modern multiagent induction chemotherapy and are then reviewed for possible surgical removal. Eligible patients will have received at least four months of induction therapy, show stable disease or partial response by RECIST 1.1, and be judged resectable by a local multidisciplinary team. Data collected will include pre- and post-induction imaging, details of any conversion surgery, surgical outcomes, survival, and patient-reported quality-of-life questionnaires. There is no randomization; outcomes of patients who undergo resection will be compared with those who remain unresected to see if conversion surgery after chemotherapy improves survival and quality of life.
Who should consider this trial
Good fit: Adults with histologically confirmed locally advanced pancreatic adenocarcinoma who completed at least four months of induction chemotherapy, show stable disease or partial response on RECIST 1.1, and are judged eligible for radical resection by the local MDT are ideal candidates.
Not a fit: Patients with metastatic disease, tumor features or comorbidities that preclude surgery, inadequate imaging before induction, or progression on induction therapy are unlikely to benefit from conversion surgery.
Why it matters
Potential benefit: If successful, this approach could allow a subset of patients with initially unresectable tumors to have surgery that prolongs survival and improves quality of life.
How similar studies have performed: Several institutional series and observational reports have suggested that conversion surgery after modern induction regimens can benefit selected patients, but high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Padova
- UOC Chirurgia Generale 2, Azienda Ospedale di Padova, Padova, Italy 35128 — Padova, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.