Clinical trial for Pancreas Adenocarcinoma
Official title Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
ClinicalTrials.gov ID: NCT06349278
What this study is testing
- What it's testing
- The study wants to see if removing the pancreas and the liver spots after chemotherapy can improve outcomes for these patients.
- Who it's for
- It is looking for adults with pancreatic cancer that can be removed and who have three or fewer liver spots that can also be removed.
- What's involved
- Participants will get 12 rounds of the chemotherapy drug FOLFIRINOX, have scans to check how the cancer responds, and then may have surgery to remove the pancreas and the liver spots. After surgery they may get more chemotherapy and will have regular scans and blood tests.
- Time commitment
- The whole process lasts about a year, with 12 chemotherapy rounds, surgery, and follow‑up scans and blood tests every few months for at least two years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- Resectable primary tumor based on triphasic CT-scan.
- ≤ 3 liver metastases.
- Liver resections can be performed by local excision or non-anatomical, partial hepatectomy.
- No evidence of extrahepatic metastases.
You likely can't join if
- Impossibility to obtain tissue diagnosis preoperatively confirming PDAC.
- Locally advanced disease on triphasic CT-scan.
- \> 3 liver metastases.
- Major hepatectomy required for liver metastases (right hepatectomy, left hepatectomy, central hepatectomy, extended right or left hepatectomy).
- Suspicion or confirmation of extrahepatic metastases.
- Patient unfit for pancreatic resection (ECOG 2 or more).
See the full eligibility criteria
- Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- Resectable primary tumor based on triphasic CT-scan.
- ≤ 3 liver metastases.
- Liver resections can be performed by local excision or non-anatomical, partial hepatectomy. Patients with complete radiologic response after neoadjuvant FOLFIRINOX (FFX), therefore not requiring liver resection, will be...
- No evidence of extrahepatic metastases.
- Patient fit for pancreatic resection (ECOG 0 or 1).
- Stable or partial response on imaging after neoadjuvant FFX.
- No new metastasis after neoadjuvant FFX
- Blood tumor markers ≥ 80% decreased or within normal values after neoadjuvant FFX.
- Impossibility to obtain tissue diagnosis preoperatively confirming PDAC.
- Locally advanced disease on triphasic CT-scan.
- \> 3 liver metastases.
- Major hepatectomy required for liver metastases (right hepatectomy, left hepatectomy, central hepatectomy, extended right or left hepatectomy).
- Suspicion or confirmation of extrahepatic metastases.
- Patient unfit for pancreatic resection (ECOG 2 or more).
- Contraindication to receive FFX.
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.