Surgery is often the first treatment attempted on newly diagnosed pancreatic cancer patients with cancer that has not spread to other parts of the body, often followed by chemotherapy and/or radiation. However, this combination approach is not always effective. Sometimes cancer metastasis evades imaging and the disease already spread before surgery. Or the surgery takes such a toll on the patient that they are unable to complete the rest of their treatment.
In this study, doctors are exploring whether assessing tumor response after the first round of treatment of neoadjuvant treatment—chemotherapy and/or radiation delivered before the main treatment—can help identify patients that are good candidates for surgery. Researchers are also asking if this approach can identify those patients with progressive disease for whom an operation has little benefit, to possibly ensure all patients receive the optimal course of treatment.
Taking an Adaptive Approach
In this study, patients with pancreatic cancer that may be surgically removable will receive the standard first-line chemotherapy of FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Their response to the pre-surgical chemotherapy will be assessed with a CT scan, an analysis of CA 19-9 levels, and an overall physical performance check. Based on the results, the next steps in treatment will be chosen.
- Patients who show a good response to the treatment will continue on the same chemotherapy regimen for an additional two months, then be offered chemoradiation and surgery if deemed suitable.
- Patients whose disease remains ‘stable’ (without a significant decline in CA 19-9 levels) will receive another type of chemotherapy such as gemcitabine, or a molecular profile-directed therapy, for an additional two months, before chemoradiation and surgery if deemed suitable.
- Patients with disease progression whose tumors can still be surgically removed will be offered chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgery is not lost.
Participating in the Trial
All patients must have removable or borderline removable tumors, with no artery involvement and no metastasis. Participants must not have had prior treatment for pancreatic cancer.
We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides more details about this trial as well as many others. You can visit the EmergingMed Trial Finder for a listing of all active pancreatic cancer clinical trials.