Neoadjuvant Therapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Cincinnati
Must not be taking: Investigational agents
Disqualifiers: Uncontrolled illness, Pregnant, Breastfeeding, others
Stay on your current meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine if neoadjuvant therapy to increases resection rate for pancreatic adenocarcinoma.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.
What data supports the effectiveness of this treatment for pancreatic cancer?
Research shows that FOLFIRINOX, a combination of drugs, is more effective than gemcitabine for patients with metastatic pancreatic cancer, leading to better survival rates. Additionally, when used as a neoadjuvant therapy (treatment given before the main treatment), FOLFIRINOX has shown promising results in improving outcomes for patients with locally advanced pancreatic cancer.
12345Is neoadjuvant therapy for pancreatic cancer generally safe for humans?
FOLFIRINOX and gemcitabine-based treatments for pancreatic cancer have different safety profiles. FOLFIRINOX may cause more vomiting and diarrhea, while gemcitabine can lead to more anemia. Both treatments are used in advanced pancreatic cancer, but their side effects vary.
678910How is the drug FOLFIRINOX different from other treatments for pancreatic cancer?
FOLFIRINOX is a combination of four drugs (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) that has shown higher response rates in treating metastatic pancreatic cancer compared to gemcitabine-based treatments. It is being explored as a neoadjuvant therapy (treatment given before the main treatment) for locally advanced pancreatic cancer, which is a newer approach compared to its use in metastatic cases.
14111213Eligibility Criteria
This trial is for adults with confirmed pancreatic carcinoma or adenocarcinoma who haven't had prior treatment for it. They must be in good health otherwise, not have other serious illnesses that could affect the study, and agree to use contraception. People with controlled HIV or cured hepatitis are eligible, but pregnant women and those unable to follow the study plan can't join.Inclusion Criteria
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
I am 18 years old or older.
I had cancer before, but it was treated over 2 years ago and won't affect this study.
+9 more
Exclusion Criteria
You are not currently taking any other experimental medications. If you have taken experimental medications in the past but are not currently taking them, the decision to include you will be made by the Principal Investigator.
Pregnant women or women who are breastfeeding are excluded from this study.
I do not have any health conditions that would stop me from receiving standard cancer treatments.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Chemotherapy
Participants receive FOLFIRINOX regimen, with potential switch to gemcitabine and nab-paclitaxel based on interim assessment
16 months
Regular visits for chemotherapy administration and assessment
Radiation Therapy
Radiation therapy may be used prior to surgery based on pre-operative scan findings
As needed prior to surgery
Surgical Resection
Participants undergo surgical resection if deemed resectable after neoadjuvant therapy
Surgery scheduled post-therapy
Follow-up
Participants are monitored for safety, effectiveness, and survival after treatment
5 years
Regular follow-up visits for monitoring
Participant Groups
The trial tests if neoadjuvant therapy (treatment given before main treatment) increases the chance of successfully removing pancreatic tumors through surgery. It involves a combination of chemotherapy drugs like Gemcitabine and Folfirinox, along with radiation therapy before a pancreatectomy.
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant therapyExperimental Treatment4 Interventions
All patients will receive Neoadjuvant therapy.
Folfirinox is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as FOLFIRINOX for:
- Pancreatic cancer
🇪🇺 Approved in European Union as FOLFIRINOX for:
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ArizonaTucson, AZ
University of Cincinnati Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
University of CincinnatiLead Sponsor
References
Outcomes with FOLFIRINOX for borderline resectable and locally unresectable pancreatic cancer. [2022]Trials examining FOLFIRINOX in metastatic pancreatic cancer demonstrate higher response rates compared to gemcitabine-based regimens. There is currently limited experience with neoadjuvant FOLFIRINOX in pancreatic cancer.
Survival Outcomes Associated With Clinical and Pathological Response Following Neoadjuvant FOLFIRINOX or Gemcitabine/Nab-Paclitaxel Chemotherapy in Resected Pancreatic Cancer. [2022]To compare the survival outcomes associated with clinical and pathological response in pancreatic ductal adenocarcinoma (PDAC) patients receiving neoadjuvant chemotherapy (NAC) with FOLFIRINOX (FLX) or gemcitabine/nab-paclitaxel (GNP) followed by curative-intent pancreatectomy.
Real-Life Results of Palliative Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma. [2023]To assess the efficacy of FOLFIRINOX(FFX), gemcitabine-based regimens (GB), and gemcitabine monotherapy (Gem) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. [2022]5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) is superior to gemcitabine in patients with metastatic pancreatic cancer who have a good performance status. We investigated this combination as neoadjuvant therapy for locally advanced pancreatic cancer (LAPC).
Pancreatic ductal adenocarcinoma: tumour regression grading following neoadjuvant FOLFIRINOX and radiation. [2023]In the adjuvant setting, when compared to gemcitabine, patients with pancreatic ductal adenocarcinoma (PDAC) treated with FOLFIRINOX (Folinic Acid, Fluorouracil, Irinotecan, and Oxaliplatin) show superior survival. In this study, we quantitatively assess the pathological tumour response to chemoradiation in pancreatectomy specimens and reassess guidelines for tumour regression grading.
Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. [2020]To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC).
Comparative Effectiveness of Gemcitabine plus Nab-Paclitaxel and FOLFIRINOX in the First-Line Setting of Metastatic Pancreatic Cancer: A Systematic Review and Meta-Analysis. [2020]Gemcitabine and nab-paclitaxel (GEM-NAB) and the combination of 5-fluorouracil, oxaliplatin, and irinotecan (FOLFIRINOX) are valid first-line options for advanced or metastatic pancreatic cancer (mPC). However, no randomized trials comparing the two schemes have been performed. This meta-analysis aims to compare GEM-NAB and FOLFIRINOX in terms of safety and effectiveness, taking into account data from real-life studies on mPC. We systematically searched PubMed, EMBASE and Cochrane library up to November 2018 to identify retrospective or cohort studies on mPC comparing GEM-NAB and FOLFIRINOX. We included 16 retrospective studies, including 3813 patients (2123 treated with GEM-NAB and 1690 treated with FOLFIRINOX). Despite a median weighted overall survival (OS) difference in favor of FOLFIRINOX (mean difference: 1.15, 95% confidence interval CI 0.08⁻2.22, p = 0.03), in whole population OS was similar (hazard ratio (HR = 0.99, 95% CI 0.84⁻1.16; p = 0.9). PFS was also not different between the two arms (HR = 0.88, 95% CI 0.71⁻1.1; p = 0.26). The overall response rate was similar (25 vs. 24% with GEM-NAB and FOLFIRINOX). Among grade 3⁻4 toxicities, neutropenia, febrile neutropenia, and nausea were lower with GEM-NAB, while neurotoxicity and anemia were lower with FOLFIRINOX. In conclusion, despite a numerically longer median OS with FOLFIRINOX as compared to GEM-NAB, the overall risk of death and progression were similar. Their toxicity was different with less nausea, neutropenia, and febrile neutropenia with GEM-NAB, as compared to less neurotoxicity and anemia with FOLFIRINOX. Therefore, analysis of non-randomized "real world" studies to date has not provided evidence of a major benefit of one regimen over the other.
Effect of FOLFIRINOX as second-line chemotherapy for metastatic pancreatic cancer after gemcitabine-based chemotherapy failure. [2022]This study aimed to determine the maximum tolerated dose (MTD), dose-limiting toxicity, and efficacy of second-line chemotherapy with FOLFIRINOX after gemcitabine (GEM)-based chemotherapy failure in metastatic pancreatic cancer (MPC).
Equivalent Efficacy but Different Safety Profiles of Gemcitabine Plus Nab-Paclitaxel and FOLFIRINOX in Metastatic Pancreatic Cancer. [2022]FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GN) are the most common chemotherapy regimens in first-line treatment of metastatic pancreatic cancer (PC). They have not been compared each other in a prospective trial, but only in retrospective studies, which can thus be affected by several biases. In order to overcome these biases, we took advantage of matching-adjusted indirect comparison (MAIC), that allows an indirect comparison by reducing cross-trial differences, and compared data from 268 patients treated with GN in a real-world setting with data from the 171 patients included in the FFX arm of the PRODIGE trial. Survival outcomes did not differ between the two populations. Overall survival was 11.1 months for both treatments (hazard ratio (HR) of FFX 1.10, 95% confidence interval (CI) 0.81-1.49; p = 0.527). Progression-free survival was 6.0 months with GN and 6.4 months with FFX (HR of FFX 1.11, 95% CI 0.82-1.50; p = 0.520). On the other hand, we observed a difference in the toxicity profiles: grade 3/4 anemia was more frequent with GN, whereas a higher occurrence of grade 3/4 vomiting and diarrhea was reported with FFX. FFX and GN show an equivalent efficacy but different safety profiles in the first-line therapy of metastatic pancreatic cancer. Searching for reliable predictive biomarkers is advised in order to improve therapeutic strategy in metastatic PC.
An assessment of the benefit-risk balance of FOLFIRINOX in metastatic pancreatic adenocarcinoma. [2022]We sought to assess the benefit-risk balance of FOLFIRINOX versus gemcitabine in patients with metastatic pancreatic adenocarcinoma.
Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis. [2022]FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, oxaliplatin) and gemcitabine plus nab-paclitaxel therapy have recently been introduced for the treatment of metastatic pancreatic cancer. Herein, overall treatment outcomes of metastatic pancreatic cancer after introduction of FOLFIRINOX and gemcitabine plus nab-paclitaxel therapy were evaluated, in daily practice.
Folfirinox versus gemcitabine/nab-paclitaxel as first-line therapy in patients with metastatic pancreatic cancer: a comparative propensity score study. [2022]Folfirinox (FFX) and gemcitabine/nab-paclitaxel (GN) are both standard first-line treatments in patients with metastatic pancreatic cancer (mPC). However, data comparing these two chemotherapeutic regimens and their sequential use remain scarce.
FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. [2023]Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.