Tailored Neoadjuvant Therapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a specific genetic marker (SMAD4 mutation) can help tailor chemotherapy treatments for pancreatic cancer that might be surgically removable. The goal is to improve outcomes by personalizing treatment rather than using a standard approach. Participants will receive various chemotherapy combinations, including drugs like Fluorouracil, Gemcitabine, Irinotecan, Nab-paclitaxel, and Oxaliplatin, to find the best fit for their cancer type. This trial may suit those with pancreatic cancer that hasn't spread and who haven't received previous treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of gemcitabine and nab-paclitaxel is generally well-tolerated by patients with pancreatic cancer. Studies have found that this treatment improves survival rates and is manageable for most people. Common side effects include tiredness, nausea, and low blood cell counts, but supportive care can usually manage these issues.
Regarding the FOLFIRINOX regimen, studies suggest it is also generally well-tolerated, though it may cause more intense side effects like a drop in white blood cells, increasing the risk of infection. However, it has demonstrated promise in improving survival rates for pancreatic cancer patients, making it a valuable option.
Both treatments have proven effective and are considered safe for use in clinical settings. This trial aims to customize these options based on specific genetic markers, potentially improving outcomes even further.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer tailored neoadjuvant therapy options for pancreatic cancer, which could better prepare tumors for surgical removal. Unlike the standard treatments such as gemcitabine and nab-paclitaxel, this trial explores the potential of combining these with FOLFIRINOX, a regimen that includes fluorouracil, leucovorin, irinotecan, and oxaliplatin. This approach might enhance the effectiveness of pre-surgical therapy and potentially improve surgical outcomes. By giving doctors the flexibility to choose between these regimens based on the patient’s specific condition, the trial aims to optimize treatment plans and improve survival rates.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial will compare different treatment regimens for pancreatic cancer. Studies have shown that treatments like gemcitabine and nab-paclitaxel, which participants in Cohort A may receive, can be effective for pancreatic cancer. Specifically, using these drugs together improved survival rates, with patients living about 13.87 months on average, compared to 8.5 months with gemcitabine alone. Research also indicates that about 48% of patients responded well to this combination.
In Cohort B, participants may receive either gemcitabine and nab-paclitaxel or FOLFIRINOX, which includes drugs like oxaliplatin and irinotecan. FOLFIRINOX has shown an average survival of 11.1 months, longer than some other treatments. It has been effective in improving survival rates, with some studies showing nearly 67% of patients surviving at 18 months. Both treatments have shown promise, but their effectiveness can vary based on individual factors.678910Who Is on the Research Team?
Brett L Ecker, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic ductal adenocarcinoma that can be removed by surgery or is borderline resectable. Participants must be able to undergo chemotherapy and surgery, and their tumor's SMAD4 gene status will help guide treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive chemotherapy with gemcitabine and nab-paclitaxel or FOLFIRINOX, with or without radiation therapy, for 8 weeks initially, with potential extension up to 24 weeks based on restaging and multidisciplinary tumor board decision.
Surgical Resection
Patients undergo surgical resection starting 21 days after the last dose of chemotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 30 days post-surgery and every 3 months for up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Fluorouracil
- Gemcitabine
- Irinotecan
- Leucovorin
- Nab-paclitaxel
- Oxaliplatin
- Radiation Therapy
Trial Overview
The study tests if tailoring pre-surgery chemotherapy based on the tumor’s SMAD4 gene improves outcomes in pancreatic cancer. Treatments may include gemcitabine/nab-paclitaxel or FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin), plus imaging and biospecimen collection.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.
Patients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Liposomal Irinotecan in Combination With Oxaliplatin ...
Recent phase 2 study results show that liposomal irinotecan combined with oxaliplatin, leucovorin, is effective and significantly improves ...
FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic ...
Panel A shows overall survival; the median was 11.1 months in the group receiving FOLFIRINOX (oxaliplatin, irinotecan, fluorouracil, and ...
Efficacy and safety of modified fluorouracil/leucovorin plus ...
Here, we evaluated the efficacy and safety of modified fluorouracil/leucovorin plus irinotecan and oxaliplatin (mFOLFIRINOX) compared with oral ...
Liposomal irinotecan plus fluorouracil/leucovorin versus ...
We found no significant differences in outcome between nal-IRI/FL and FOLFIRINOX treatment. •. Both regimens were well tolerated; however, ...
Preoperative combination chemotherapy improved survival ...
FOLFIRINOX had an 18-month overall survival (OS) rate of 66.7%, exceeding both the preselected historical control rate of 50% and the OS rate ...
FOLFIRINOX for Pancreatic Cancer
Studies have shown that FOLFIRINOX, a chemotherapy treatment for pancreatic cancer, is generally well-tolerated by patients. This treatment combines four drugs: ...
The role of FOLFIRINOX in metastatic pancreatic cancer
The main adverse events (AEs) targeted hematological toxicity and the gastrointestinal system, FOLFIRINOX is generally safe and tolerable.
Folfirinox versus gemcitabine-cisplatin combination as first- ...
The median overall survival was 18.1 months (7.5–28.7) in the folfirinox group as compared with 9.7 months (6.5–13) in the gemcitabine-cisplatin ...
Effect of FOLFIRINOX as second-line chemotherapy for ... - PMC
The most common severe adverse event was neutropenia (66.7%). Febrile neutropenia occurred in 1 (5.6%) case.
Survival Outcomes Based on Sequence of Therapy Using ...
Results: The study included 3027 patients. The median OS for 1L FOLFIRINOX versus nab-p/gem was 8.6 versus 6.1 months (hazard ratio, 0.77; 95% ...
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