Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

NCT06349278 | Recruiting DMC

• 1 other identifier: 2024-7276
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or \< 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued.

Conditions

Pancreas Adenocarcinoma; Pancreas Metastases; Pancreas Cancer

Keywords

PDAC; Liver metastases; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Morbidity and mortality

  Post-operative complications

  90 days

Secondary Outcomes (1)

• Overall survival

  3 years after surgery

Study Arms (1)

Intervention

EXPERIMENTAL

Patients will undergo surgery for primary pancreatic cancer and liver metastases.

Procedure: Pancreatic resection and non-anatomic liver resections.

Interventions

Pancreatic resection and non-anatomic liver resections. PROCEDURE

Pancreatic resection and non-anatomic liver resections.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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. Patients with complete radiologic response after neoadjuvant FOLFIRINOX (FFX), therefore not requiring liver resection, will be included.
• 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.

You may not qualify 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).
• Contraindication to receive FFX.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

CHU de Québec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

Related Publications (15)

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  PMID: 30207593 BACKGROUND

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  PMID: 26314780 BACKGROUND

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  PMID: 21561347 BACKGROUND

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  PMID: 24131140 BACKGROUND

• Chun JW, Lee SH, Kim JS, Park N, Huh G, Cho IR, Paik WH, Ryu JK, Kim YT. Comparison between FOLFIRINOX and gemcitabine plus nab-paclitaxel including sequential treatment for metastatic pancreatic cancer: a propensity score matching approach. BMC Cancer. 2021 May 11;21(1):537. doi: 10.1186/s12885-021-08277-7.

  PMID: 33975561 BACKGROUND

• Otsuka T, Shirakawa T, Shimokawa M, Koga F, Kawaguchi Y, Ueda Y, Nakazawa J, Komori A, Otsu S, Arima S, Fukahori M, Okabe Y, Makiyama A, Taguchi H, Honda T, Shibuki T, Nio K, Ide Y, Mizuta T, Mitsugi K, Ureshino N. A multicenter propensity score analysis of FOLFIRINOX vs gemcitabine plus nab-paclitaxel administered to patients with metastatic pancreatic cancer: results from the NAPOLEON study. Int J Clin Oncol. 2021 May;26(5):941-950. doi: 10.1007/s10147-021-01859-2. Epub 2021 Jan 23.

  PMID: 33483857 BACKGROUND

• Lee JC, Woo SM, Shin DW, Kim J, Yang SY, Kim MJ, Kim JW, Kim JW, Lee WJ, Cha HS, Park P, Kim J, Hwang JH. Comparison of FOLFIRINOX and Gemcitabine Plus Nab-paclitaxel for Treatment of Metastatic Pancreatic Cancer: Using Korean Pancreatic Cancer (K-PaC) Registry. Am J Clin Oncol. 2020 Sep;43(9):654-659. doi: 10.1097/COC.0000000000000730.

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MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alexandre Brind'Amour, MD, MSc

  CHU de Québec

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Brind'Amour, MD, MSc

CONTACT

418-691-5370; alexandre.brindamour.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: One group will undergo intervention prospectively.

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: January 16, 2024
• Primary Completion: January 16, 2026
• Study Completion (Estimated): January 16, 2029
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)