Prediction of Surgical Resectability After FOLFIRINOX Chemotherapy for Borderline Resectab
In this prospective study, new diagnostic tools will be explored for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (BR or LAPDA) who undergo neoadjuvant chemotherapy with FOLFIRINOX. The diagnostic work-up and therapy for the study population will not differ from the gold sta
| Condition(s) | Pancreatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | In this prospective study, new diagnostic tools will be explored for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (BR or LAPDA) who undergo neoadjuvant chemotherapy with FOLFIRINOX. The diagnostic work-up and therapy for the study population will not differ from the gold standard during the study; only additional diagnostic tools will be implemented, and their value will be analyzed post hoc. The 5-year survival rate of pancreatic cancer is 9%, but this can be drastically improved if surgery is possible. With its increasing incidence and poor prognosis, pancreatic cancer is becoming a global oncologic challenge where major breakthroughs are still required to improve patient outcomes. Patients with BR or LAPDA typically undergo neoadjuvant treatm |
| Who can participate | Inclusion Criteria: * Male or female patients, aged 18 years and above * Diagnosis of BR or LA PDAC according to NCCN guidelines (version 1.2020) * Histologic diagnosis of PDAC * No medical or anesthetic contra-indication for surgery * Able to understand nature of the study procedures * Willing to participate and give written informed consent Exclusion Criteria: * Age \< 18 years * Distant metastases * Histologic diagnosis of cholangiocarcinoma, duodenal carcinoma or neuroendocrine tumor * Known hypersensitivity for MRI contrast * Pacemaker or prosthesis with incompatibility for MRI * Claustrophobia * Pregnancy or breastfeeding * Not able to understand nature of the study procedure * Performance status ECOG score: \>2 |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University Hospital, Ghent |
| Locations | Ghent, East Flanders, Belgium; Dendermonde, Belgium; Eeklo, Belgium; Ghent, Belgium; Ghent, Belgium; Oudenaarde, Belgium (+2 more sites) |
| Start date | 2022-12-12 |
| NCT ID | NCT05298722 |
| Official listing | https://clinicaltrials.gov/study/NCT05298722 |