Chemotherapy for Pancreatic Cancer

(NeoPancOne Trial)

Not currently recruiting at 8 trial locations

Overseen By Anna Dodd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: mFFX

Must not be taking: QT prolonging medications

Disqualifiers: Metastatic disease, Unresectable PDAC, Active hepatitis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a chemotherapy treatment called modified Folforinox (mFFX) for individuals with resectable pancreatic cancer. The researchers aim to determine if using this treatment before and after surgery can improve patient outcomes and help tailor future treatment strategies. They also seek to understand how certain biological markers (biomarkers) might indicate who benefits most from this approach. Individuals with confirmed pancreatic ductal adenocarcinoma (a type of pancreatic cancer) that is considered operable and who have not received any previous cancer treatments might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could shape future treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain medications like coumadin (a blood thinner) and cannot switch to another type, you may not be eligible to participate.

Is there any evidence suggesting that modified Folforinox (mFFX) is likely to be safe for humans?

Research has shown that the modified FOLFIRINOX (mFFX) treatment is generally safe and well-tolerated for people with pancreatic cancer. One study found that altering the traditional FOLFIRINOX treatment made it safer, reducing side effects such as nausea and diarrhea. Another study demonstrated that the risk of fever and infection was lower with mFFX compared to the original treatment. This suggests that mFFX might be easier for patients to handle. Additionally, mFFX is recommended as a treatment after surgery for pancreatic cancer, indicating its safety for regular use in that context. Overall, mFFX appears to be a promising option for treating pancreatic cancer, with a better safety profile than the original treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Modified Folforinox (mFFX) is unique because it combines several chemotherapy agents into a powerful regimen specifically designed for pancreatic cancer. Unlike other treatments that may follow surgery, mFFX is used as a neo-adjuvant therapy, meaning it's given before surgery to shrink tumors, potentially making them easier to remove. This approach can lead to better surgical outcomes and, importantly, might provide a more comprehensive attack on cancer cells by combining it with surgery and additional chemotherapy cycles. Researchers are excited about mFFX's potential to improve survival rates and quality of life for patients with pancreatic cancer.

What evidence suggests that modified Folforinox (mFFX) might be an effective treatment for pancreatic cancer?

Research has shown that a treatment called modified FOLFIRINOX (mFFX), which participants in this trial will receive, works well for pancreatic cancer. In one study, patients who received mFFX lived for an average of 54.4 months, while those who received a common chemotherapy drug called gemcitabine lived for an average of 35.0 months. This indicates that patients lived longer with mFFX. Another study suggested using mFFX as an additional treatment after surgery for pancreatic cancer. Additionally, mFFX is considered safer and easier for patients to manage due to modifications made to the treatment. These findings suggest that mFFX could effectively improve outcomes for pancreatic cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer J. Knox, MD, MSc

Principal Investigator

Princess Margaret Cancer Centre, University Health Network

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed pancreatic ductal adenocarcinoma (PDAC) that can be surgically removed. They must be fit for surgery and the mFFX chemotherapy, have no prior cancer treatments, and no evidence of metastases or other primary cancers in the last 3 years. Participants need proper liver and blood function, not be pregnant or breastfeeding, agree to use contraception if applicable, and provide consent.

Inclusion Criteria

My doctor agrees I can handle mFFX treatment.

My cancer has not spread to major arteries near my liver and stomach.

I have been diagnosed with pancreatic cancer, confirmed by a specific biopsy.

Exclusion Criteria

I have a history of heart rhythm issues or take medication that affects my heart rhythm.

My pancreatic cancer cannot be removed by surgery, as confirmed by scans.

I've had two unsuccessful attempts to confirm pancreatic cancer through EUS-FNB.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neo-adjuvant Chemotherapy

Participants receive neo-adjuvant mFFX chemotherapy for up to 6 cycles

12-18 weeks

Surgery

Participants undergo surgery for resectable pancreatic adenocarcinoma

Adjuvant Chemotherapy

Participants receive adjuvant chemotherapy for up to 6 cycles

12-18 weeks

Follow-up

Participants are monitored for disease-free survival and other outcomes

2-4 years

What Are the Treatments Tested in This Trial?

Interventions

• Modified Folforinox (mFFX)

Trial Overview

The study tests how well patients with resectable pancreatic cancer respond to a chemotherapy regimen called modified Folforinox (mFFX) before and after surgery. It also examines whether GATA6 expression levels can predict treatment outcomes. This Canadian multicentre trial aims to personalize future treatment strategies.

How Is the Trial Designed?

Group I: Neo-adjuvant mFFX Experimental Treatment 1 Intervention

Neo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Pancreatic Cancer Canada

Collaborator

Trials

2

Recruited

100+

Published Research Related to This Trial

In a study of 243 patients with advanced pancreatic adenocarcinoma treated with FOLFIRINOX, the relative dose intensity (RDI) of the treatment agents did not significantly correlate with disease control or objective response, suggesting that dose reductions may not compromise treatment effectiveness.

The median cumulative multi-drug RDI was 80%, and including RDI in predictive models did not enhance the ability to forecast disease control, indicating that oncologists can safely adjust doses without fearing a loss of therapeutic benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FOLFIRINOX relative dose intensity and disease control in advanced pancreatic adenocarcinoma. Vary, A., Lebellec, L., Di Fiore, F., et al.[2022]

Modified-dose FOLFIRINOX (mFOLFIRINOX) demonstrated comparable efficacy to standard-dose FOLFIRINOX (sFOLFIRINOX) in treating pancreatic cancer, with similar objective response rates and overall survival outcomes among 130 patients studied.

mFOLFIRINOX was associated with significantly lower rates of severe adverse events, such as neutropenia, anorexia, and diarrhea, suggesting it is a safer option for patients who may be concerned about toxicity while maintaining effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer. Kang, H., Jo, JH., Lee, HS., et al.[2022]

In a study of 54 patients with advanced pancreatic cancer, S-IROX showed a higher disease control rate (73.7%) compared to modified FOLFIRINOX (mFFX) (62.2%), indicating it may be more effective as a second-line treatment after gemcitabine plus nab-paclitaxel.

Both S-IROX and mFFX had similar overall survival rates (14.2 months for S-IROX and 11.5 months for mFFX) and tolerability, with no significant differences in severe side effects, suggesting both regimens are viable options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparative study of S-IROX and modified FOLFIRINOX for patients with advanced pancreatic cancer refractory to gemcitabine plus nab-paclitaxel. Saito, K., Nakai, Y., Takahara, N., et al.[2022]

In a study of 318 patients with metastatic pancreatic cancer, the modified FOLFIRINOX (mFFX) regimen showed similar overall survival and progression-free survival compared to the original FOLFIRINOX (oFFX) regimen, indicating that mFFX is just as effective.

mFFX was associated with significantly fewer adverse events, such as thrombopenia and liver dysfunction, making it a safer option for patients compared to oFFX.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Retrospective Analysis of Original versus Modified FOLFIRINOX in Metastatic Pancreatic Cancer: Results of the NAPOLEON Study. Nakazawa, J., Tsuruta, N., Shimokawa, M., et al.[2023]

In a study of 198 patients with advanced pancreatic cancer, the SOXIRI chemotherapy regimen showed similar overall survival (12.1 months) and progression-free survival (6.5 months) compared to the standard mFOLFIRINOX regimen (11.2 months and 6.8 months, respectively), indicating comparable efficacy.

While both regimens had similar safety profiles, SOXIRI was associated with a higher incidence of anemia (41.4% vs. 24%), suggesting that while effective, it may have specific side effects that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of SOXIRI versus mFOLFIRINOX in advanced pancreatic cancer. Li, X., Huang, J., Wang, F., et al.[2023]

The modified FOLFIRINOX (mFOLFIRINOX) regimen demonstrated a high treatment efficacy in patients with locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer (MPC), achieving a response rate of 55.2% among 29 evaluable patients.

The treatment was well-tolerated, with only 9 patients experiencing grade 3 or 4 adverse effects, and no patients discontinued treatment due to side effects, indicating a favorable safety profile for this regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modified FOLFIRINOX for advanced pancreatic cancer: a tertiary center experience from China]. Bai, X., Su, R., Ma, T., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6589737/

Modified FOLFIRINOX for resected pancreatic cancer

The median overall survival was 54.4 mo in the modified FOLFIRINOX group vs 35.0 mo in the gemcitabine group (stratified HR for death = 0.64; 95%CI: 0.48-0.86; ...

2.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2795978

Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as ...

The results of this randomized clinical trial found modified FOLFIRINOX to be a recommended adjuvant regimen following PDAC resection.

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e16252

Favourable outcomes in locally advanced and metastatic ...

Favourable outcomes in locally advanced and metastatic pancreatic cancer treated with modified FOLFIRINOX as second-line chemotherapy.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6519772/

Association of Modified‐FOLFIRINOX‐Regimen‐Based ...

Modification of FOLFIRINOX significantly improves safety and tolerability in Chinese patients with locally advanced pancreatic cancer.

5.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1809775

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for ...

Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer.

6.

link.springer.com

link.springer.com/article/10.1007/s12029-025-01309-6

Clinical Outcome and Safety of Triweekly Modified ...

Triweekly mFFX therapy may be a feasible treatment option for unresectable pancreatic cancer, potentially reducing toxicity and helping to ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11275028/

Safety and Feasibility of Neoadjuvant-Modified FOLFIRINOX ...

Thus, in this study, we investigated the safety and feasibility of neoadjuvant mFOLFIRINOX in elderly patients with PC. We found that the ...

8.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(19)46893-2/fulltext

Safety and efficacy of modified FOLFIRINOX in patients ...

The incidence rates of FN (7% vs. 22%), nausea (55% vs. 89%) and diarrhea (36% vs. 86%) were lower in our study population as compared to those in the PII. The ...