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NALIRIFOX + Radiation for Pancreatic Cancer
Phase 2
Recruiting
Led By Alice Wei, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates if a combination of drugs and radiation therapy can effectively treat pancreatic cancer in combination with surgery, and with few side effects, and measure quality of life.
Who is the study for?
This trial is for adults over 18 with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) that hasn't been treated before. They must be in good health, have no history of certain cancers within the last 5 years except some specific types, and women must not be pregnant and agree to birth control measures. Men must also agree to use contraception.
What is being tested?
The study tests a chemotherapy regimen called NALIRIFOX combined with ablative dose radiation therapy (AD-XRT) and capecitabine before surgery in patients with PDAC. It aims to assess if this total neoadjuvant therapy (TNT) sequence is effective and tolerable, while also monitoring participants' quality of life through questionnaires.
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as fatigue, digestive problems like nausea or diarrhea, blood cell count changes leading to increased infection risk, possible liver function alterations, and reactions related to the infusion process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
event-free survival (EFS)
Secondary study objectives
overall survival (OS) rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NALIRIFOX + AD-XRT and capecitabineExperimental Treatment2 Interventions
Patients will receive neoadjuvant chemotherapy for 4 months. Patients will undergo a CT scan at 8 weeks and 16 weeks after the start of neoadjuvant chemotherapy to assess treatment response. Patients without disease progression will then undergo AD-XRT for 15 to 25 fractions (3 to 5 weeks). Patient's whose disease is deemed resectable based on their re-evaluating imaging, will be recommended surgical intervention with consideration for laparotomy or laparoscopy if deemed appropriate at multidiscplinary cancer conference review.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,018 Total Patients Enrolled
IpsenIndustry Sponsor
352 Previous Clinical Trials
74,330 Total Patients Enrolled
Pancreatic Cancer Research FundUNKNOWN
1 Previous Clinical Trials
3,500 Total Patients Enrolled
Alice Wei, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
29 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult over 18 and not pregnant or breastfeeding.I was diagnosed and treated for certain early-stage cancers or skin cancer within the last 5 years.I am willing and able to follow the study's procedures and attend all visits.I do not have any infections that could make treatment dangerous, except for possibly resolving cholangitis.I agree to use two forms of birth control during and for 9 months after the study.My white blood cell count is healthy without needing medication to boost it.I am fully active or can carry out light work.My cancer cannot be removed by surgery, but I have recovered from the surgical exploration.My kidney function is good, with creatinine levels below 1.6 mg/dL.My treatment plan was agreed upon by a team of cancer specialists.I have health conditions that make major abdominal surgery too risky.I have had chemotherapy, radiotherapy, or surgery for pancreatic cancer.I've been cancer-free from another type for 2+ years and at low risk of it coming back.I am not pregnant or have been without a period for at least 2 years.I do not have severe nerve pain or damage.My cancer is not adenocarcinoma, but adenosquamous types are okay.I agree to use condoms for 4 months after the last dose of the study medication.My pancreatic cancer is confirmed but not yet treated.My pancreatic cancer has spread to other parts of my body.My blood clotting time is normal or managed if I'm on blood thinners.My pancreatic cancer is locally advanced without spread to distant parts.
Research Study Groups:
This trial has the following groups:- Group 1: NALIRIFOX + AD-XRT and capecitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.